Tip:
Highlight text to annotate it
X
>> So you're in the home stretch.
You're getting there.
This is the next couple hours are going to be
on something new and different.
Many of you may have heard of the coming changes
to ventilator associated pneumonia surveillance.
And I'm glad to be able to share with you some
of the details of that today.
So what I'm going to go through is really the who, what, when,
why, and how of VAE, or ventilator associated events,
but not necessarily in that order.
So we'll start first with some of the why.
Why we made this change, what's the background,
what's the rational for VAE surveillance instead
of for VAP surveillance.
Then we'll talk about who's eligible for VAE surveillance
and when it's actually going to be available
in the NHSN application.
We'll go into what is VAE with a rather detailed review
of the surveillance definitions.
And then we're going to spend some time talking
about how you should prepare for and conduct the VAE surveillance
and some of the key terms that you'll need to know.
In that process, we'll talk about some of the pearls
and pitfalls that we know about at this point.
We'll go through denominators and VAE rate calculations.
I'll mention some of the tools we hope to make available
to you soon and finally go through some take-home points.
So what we'll do, I'll go through the presentation.
I think we'll have plenty of time at the end for questions.
So might be best to hold off till that point
to ask your questions.
So why VAE?
So just to put this in context,
I'm going to summarize the problem a little bit for you.
This is probably obvious to many of you,
but VAP is obviously an important complication
of mechanical ventilation, but it's not the only bad thing
that happens to patients who are on mechanical ventilators.
There are lots of other events, acute respiratory syndrome,
atelectasis, pulmonary edema, pulmonary embolism.
There are lots of other things that can happen in the course
of mechanical ventilation.
Current, there's no valid reliable definition for VAP.
Whether it's definitions or diagnostics we use
at the bed side, in clinical research, or in public health.
So we really do need more accurate diagnostics.
But until those are available we're still in a position
of needing to conduct surveillance and be able
to track preference progress in critically ill patients.
The commonly used definitions that are out there
for VAP all include some subjective elements,
and they're neither sensitive nor specific for VAP.
And this is particularly challenging in an era
of public reporting of HAI rates,
comparisons among facilities in an era where pay
for performance programs are also active.
So we felt a new approach was needed.
And just to remind you about the current new
or pneumonia surveillance definitions in NHSN,
these involve a combination of x-ray criteria,
signs and symptoms, and laboratory criteria.
There are three sets of criteria, new 1, new 2,
and new 3, with some extra sets of alternate new 1
or clinical pneumonia criteria for children and for infants.
And as you know, chest imaging findings are required
in all cases.
Signs and symptoms are required,
and laboratory evidence is optional, but if it's available
from an acceptable intratracheal type it should be used.
Ventilator association is not in and of itself, or VAP is not in
and of itself a separate definition, it's a criterion
that states that in order to be a VAP that intratracheal tube
or ventilator must have been in place
at some time during the 48 hours proceeding or at the time
of onset of the pneumonia event.
And as you know, there's no required amount of time
that that intratracheal tube must have been in place
for a new to count as a VAP.
And that's in contrast to what many clinicians use
at the bed side.
So I'd just like to mention some of the limitations
of the current VAP definitions,
and these include the definitions we use current
for surveillance in NHSN, as well as things
like the clinical pulmonary infection score,
which you may have heard of,
the European surveillance VAP definitions.
All of these use combinations of criteria.
They incorporate chest x-ray evidence
which we know lacks specificity for VAP.
There's also a lot of intra observer variability.
And in most cases, reading or interpreting chest x-rays
or even the report is not necessarily
within the per review of infection prevention expertise
and may require consultation
with other providers in your facilities.
Clinical signs and symptoms also lack sensitivity
and specificity.
Some are highly subjective, as you know, and may
or may not be well documented in the medical record.
And finally, most of these definitions do incorporate micro
biological evidence, again lacking sensitivity
and specificity for VAP.
Practices vary among providers, both in terms
of how those specimens are obtained
and then how the laboratory processes those specimens,
and there's quite a bit of controversy about best practices
for both of those aspects of obtaining the micro evidence.
So when we look at what's been happening
with VAP incidence rates in NHSN, going back to 2002
when the definitions were last changed we can see these four
major types of intensive care units, so medical ICU's,
the two categories of medical-surgical ICU's
and surgical ICU's, the rates have been coming down,
and coming down fairly dramatically since that time.
We hope that that's largely due
to evidence-based prevention measures.
But I think it's important
that we consider other reasons as well.
And I'll just point you to this commentary
that Dr. Michael Klompas published
in the American Journal
of Infection Control earlier this year about ways
that VAP rates can be lowered
without really improving patient care.
And that includes things
like strictly interpreting the clinical signs that are included
in the surveillance definitions,
strictly interpreting the chest x-ray findings,
requiring a consensus approach to VAP determination
or requiring physician approval of cases,
and also transferring patients
out who need prolonged mechanical ventilation and be
at higher risk for VAP.
And of course all of these things will serve
to decrease your numerator.
In addition, admitted uncomplicated,
mechanically ventilated post-operative patients
to an ICU may serve to increase the denominator,
the number of ventilator days, and lower rate in that regard.
So with these things in mind we did set
out to modify the NHSN approach, with the goals
of achieving phase validity and clinical creditability,
improving reliability, and reducing the burden.
And this has been a multi-year process.
We started back with VALRI,
Ventilator Associated Lower Respiratory Infection,
back in 2009.
We evaluated a draft definition in collaboration
with the CDC prevention epicenters.
The definition was largely based on work that Mike Klompas
and his colleagues have done.
And we received some expert feedback
on these draft definitions at a couple of meetings sponsored
by the Department of Health and Human Services.
Made some changes, and in 2011 moved from VALRI
to stream lined VAP, or S VAP,
in a particularly salient event during 2011 was the funding
of an epicenter proposal to evaluate the feasibility
as well as, importantly, the preventability
of events detected by an S VAP definition.
And then moving from 2011 into 2012 from S VAP
to ventilator associated events,
we convened a VAP surveillance working definition group
with the critical care societies as well as other organization
and associated representatives.
And this group has done a lot of work
to actually finalize this new approach to surveillance
that will be implemented in January.
And I just wanted to point out to you the various organizations
that were part of this working group process,
as well as the representatives and members of the working group
from each of those different societies and organizations,
and just give a big thank you to all of them for all
of the hard work that they've done over the past year.
The working group finalized a tiered approach.
So we have a VAE surveillance definition algorithm
that has three tiers.
Tiers one and two are specifically designed
to be suitable for the potential use in public reporting.
And so we have objective, general measures of VAC,
Ventilator Associated Conditions, and I VAC
or Infection Ventilator Associated Complications,
in these first two tiers.
And I just want to point out the definitions are very similar
to the tier one VAC definition have been evaluated,
again by Dr. Klompas and his colleagues.
And did identify events that were associated
with important clinical outcomes, like longer length
of stay, longer duration
of mechanical ventilation, and mortality.
They were also more efficient to apply
than the current VAP definitions.
Tier 3 are definitions that were designed for internal use.
So for internal quality improvement.
And these were called possible VAP and probable VAP,
and incorporate laboratory evidence.
And I just want to point
out that this is not a clinical definition algorithm,
it's a surveillance algorithm, and it's not intended to be used
in the management of patients.
So let's talk a little bit about the who and the
when of the AE surveillance.
So who's eligible?
Right now just adults are available for AE surveillance,
so patients who are 18 years of age and older.
In addition, patients in acute care hospitals,
long-term acute care hospitals,
and in-patient rehabilitation facilities are eligible.
So who's not eligible?
Well I just said it's just for adults.
So children are not eligible at this point for AE surveillance.
We do not have an appropriate V A algorithm for use
in kids at this point.
In patients of other times
of facilities would not be eligible.
And importantly, patients on high frequency ventilation
or Extra-Corporeal Life Support, or ECMO as it's sometimes known,
are also not El visible for VAE surveillance.
I want to say a few words
about mechanical ventilation and life support.
If this is not your area, this is not intended
to provoke any worry or any anxiety.
It's not really necessarily important that you know a lot
about any of these types of mechanical ventilation,
but that you understand there are colleagues
in your facilities that you can go to, to say do we do this,
do we have patients on this type
of mechanical ventilation in our hospital.
So you can figure out how often you're going to have to worry
about these inclusions and exclusions.
So again, if patients are on high frequency ventilation
or on extra-corporeal life support, they're excluded.
My understanding is that those are more frequently used
in children and not as much in adults.
So that may not be a major concern for many of you.
Patients who are receiving a conventional mode
of mechanical ventilation but getting other types of therapy
that may be considered more rescue therapies
like nitric oxide or Epoprostenol included
because the algorithm is is based on changes
that could be assessed
in a patient receiving conventional
mechanical ventilation.
And then finally I want to mention something
about a mode called airway pressure release ventilation,
or A P R V. Our working group had a lot
of discussion about this.
In some facilities this may rarely or never be used.
In some facilities,
my understanding is busy becoming more commonly used.
These patients are included in surveillance,
but because of the way
that ventilation is done the VAC event would be determined
by changes in the fraction of inspired oxygen only.
So our PEEP criterion, which I'm going to tell you
about in a minute, would not be able
to be used in those patients.
And again, I will just encourage you, as I will later
in the presentation as well, to talk with your respiratory care
or respiratory therapy department or critical care.
They could really help you sort out if any
of these things are things you need to be thinking
about when you're preparing to do VAE surveillance.
So
VAE surveillance is on track to be available
in NHSN in January of 2013.
So at that point the application should be able
to accept your reports.
And I just want to say a few words
about what's happening to pneumonia or VAP.
So in 2013, the current VAP protocol will still be used
for neonatal and pediatric patients only.
So in-plan VAP surveillance will still be available
for pediatric patients and for neonates.
We have recently convened a working group to talk
about modifying the VAE surveillance approach
to be appropriate for pediatric patients and for neonates.
But that's going to be a longer process.
We're not ready for VAE yet in children.
In 2013 as well, the current pneumonia definitions will still
be available for off-plan surveillance of VAP in adults
and for off-plan surveillance of non-ventilated pneumonia
in adults or children.
So hopefully that makes sense.
So let's go through what VAE is.
So this is a summary of the algorithm.
So at the top, the first part of the algorithm,
we have a respiratory status component.
This requires that the patient be on mechanical ventilation
for more than two days and that the patient have a baseline
period of stability or improvement on the ventilator,
followed by a sustained period of worsening oxygenation.
This will define a ventilator-associated condition.
The second part of the algorithm is the infection
or inflammation component.
And if the patient in addition to VAP has some general evidence
of infection or inflammation
that will define an infection-related ventilator
associated complication or an I VAC.
And then finally at the bottom of the algorithm,
incorporating some results of micro biological testing,
you can get to the internal use definitions
of positive possible or probable VAP.
So no chest x-ray is needed.
It is not part of this algorithm.
The first part of the algorithm, the VAP part,
is based on changes in FI02, that's the fraction
of inspired oxygen or PEEP
which is positive-end expiratory pressure.
The I VAC part of the algorithm is based
on abnormal temperatures or abnormal white blood cell count,
and a new antimicrobial agent being started
and continued for a period of time.
And again at the bottom here, we incorporate criteria
such as purulent respiratory secretions
or other positive laboratory evidence.
And just to emphasize again, these two top tiers
in the orange boxes, these are the definitions the working
group developed with the idea
of possible future public reporting.
The bottom tier in yellow, possible or probable VAP,
is there for internal quality improvement purposes.
So let's get into the details of this.
So tier 1 or VAC.
I mentioned that the patient has to have a baseline period
of stability or improvement on the ventilator.
And that's defined by at least two calendar days of stable
or decreasing daily minimum or FI02 PEEP values.
Following that baseline period, the patient would have
to meet one of the two criteria in that red box.
Either an increase in the daily minimum FI02
of at least 20 points over the daily minimum FI02
in the baseline period.
Or an increase in the daily minimum PEEP
of at least 3 centimeters of water over the daily minimum
in the baseline period.
In these cases, these increases have to be sustained
for at least two calendar days.
For I VAC, this is only in patients
who have met criteria for VAC.
They have to have within a defined period of time
around the onset of that VAC event and after two days
of mechanical ventilation and abnormal temperature
or an abnormal white blood cell count, and they have
to have been started on a new antimicrobial agent,
and have been continued on that agent or agents
for at least four calendar days.
Moving to possible VAP.
Again, this is only for patients
who have met the I VAC definition.
And again, within this period of time around the onset of VAC,
the patient would have to have either purulent respiratory
secretions defined in a quantitative
or semi-quantitative way, or a positive culture.
And that can be a qualitative culture,
a semi-quantitative culture, or a quantitative culture of any
of the respiratory intratracheal types
that are listed in that red box.
We're going to go through that in more detail.
There are some important organism exclusions here so that
if you have a culture that's positive
for normal respiratory flora or mixed flora
or some other result similar to that for candida species
or unspecified yeast
for a coagulative negative staph species or enterococcus.
Those are excluded.
So you can't use positive cultures just
for those organisms in making a possible
or probable VAP determination.
Moving to probable, again, patients have
to have already met I VAC.
And in this case, they would have to have purulent secretions
and a positive culture, and that positive culture has
to meet certain defined quantitative
or semi quantitative criteria.
And again you can see the intratracheal types listed here,
and we can go through them.
Or the patient would have to have one
of the bulleted criteria in the second box.
So that means a positive plural fluid culture,
positive lung histopathology or a positive diagnostic test
for a regional species or the respiratory viruses
that are listed there.
This is a screen shot of what the --
kind of the middle section
of our VAE form is going to look like.
Just to give you a sense.
We are going to ask that you record the location
where mechanical ventilation was initiated as well
as the date it was initiated.
And at least initially we want you to either circle yes or no
if the patient was on that APRV mode of mechanical ventilation
at the time of the event.
In many cases, that may always be no in your facility.
But we're trying to get a handle
on whether we need to make modifications
to the algorithm to account for these patients.
Then you'll check the specific event that you've identified.
And then you'll be checking boxes for the various criteria
that were met here in the middle section of the form.
Moving from step one, which is VAP, to step 2, which is I VAP,
then to step 3, possible and probable VAP.
So this may be a question that you're wondering,
do I have to use the entire algorithm, could I decide
that I'm only going to conduct surveillance
for I VAC, for example.
The answer to that, at least for 2013, is that yes,
you do have to use the entire algorithm.
In 2013, conducting in planned VAE surveillance will mean
assessing patients for all events, from VAP, to I VAP,
to possible or probable VAP.
And there is a hierarchy for reporting,
so that if a patient meets criteria for VAP
and I VAP you're going to report it as an I VAP.
If they met criteria for VAP, I VAP, and possible VAP,
you're going to report it as a possible VAP.
If they met VAP, I VAP, and probable,
you'd report it as a probable VAP.
And finally, if they met all four
of the definitions then you'd report as a probable VAP.
So let's talk about how you can prepare for
and how you would conduct the VAE surveillance and go
through some key terms.
So the first thing I think would be helpful is
to read the surveillance protocol.
There is a draft version of the protocol posted
on the NHSN web site as of a couple of days ago.
This is the link to it.
I just want to caution you, though,
we're actually posting a new version today.
We wanted to get it up so people who were interested and wanted
to get that jump-start can start looking at it now.
But just recognize that you're going to want to go back in 2013
and make sure you got the most up-to-date version.
The current version, the only thing that's really changing
when we post the new version is the antimicrobial criterion,
part of the I VAP definition
which I'll talk about in a minute.
But it is there for you to look at.
There are some frequently asked questions
at the back that may be helpful.
So I want you to have a look at that.
I think you also want to think about your surveillance partners
in the ICU or other units you may want to do VAE surveillance.
And these will include respiratory therapists
in your facility and critical care providers.
These folks will be really important, I think,
in helping you to understand where you can access
that daily minimum PEEP in FI02 that they collect and record
on a regular basis throughout the day.
So many of you may have great relationships with those folks
and may want to enhance that by involving them
in the surveillance.
For some of you, maybe those aren't groups you worked
with before.
So just encourage you to reach out to them and start thinking
about how -- how they can help you to do the surveillance
in a more efficient way.
I also encourage you to find out from your hospital lab,
if you don't already know already, whether Gram stain
or culture results
of respiratory secretions are reported in a semi-quantitative
or a quantitative way.
And if they're reported in a semi-quantitative way find
out if the lab knows what quantitative range those
semi-quantitative result correspond to.
That's important for possible and probable VAP.
And then perhaps most importantly is thinking
about how you're going to organize the data elements
that you need to identify VAEs, again, to make this as efficient
and stream lined as possible for you.
So I've just shown an example here of a table
that incorporates most of the criteria that we'd use
in making a VAE determination.
So for each patient you would basically be looking
at the vent day, you'd be recording the daily minimum PEEP
and FI02, and if necessary the other criteria
for the other definitions, and we're going to go
through some examples of how you would use those in a minute.
Ventilator -- mechanical ventilation
and ventilator is defined exactly as it is current.
So that has not changed at all.
A device to assist or control respiration continuously,
inclusive of the weaning period through a tracheostomy
or endotracheal intubation.
There's no change from the current definition.
We have defined an episode of mechanical definition.
So for VAE, this is a period of days during
which of the patient was mechanically ventilated
for some portion of each consecutive day.
A break in the mechanical ventilation
of at least one full calendar day followed by reintubation
and reinitiation of mechanical ventilation during the same
hospital stay is a new episode.
And that's important when patients are extubated
and reintubated in deciding how you would use surveillance
for VAE.
And I think that will become more apparent during our case
studies that Cindy is going to go through.
Many of you may already know what positive
and expiratory pressure is,
but we do just provide a concise definition in the protocol,
and I shared it with you today.
This is from Stedman's Medical Dictionary.
So a technique used in respiratory therapy
in which airway pressure greater
than atmospheric pressure is achieved at the end
of exhalation by the introduction
of mechanical impedance to exhalation.
In patients who are on mechanical ventilation
or conventional mechanical ventilation this is one
of the parameters that a provider can adjust depending
on the patient's oxygenation needs, and it is one
of the criteria that we use to assess worsening oxygenation
as part of the VAE surveillance algorithm.
Again, a sustained increase in the minimum daily PEEP
of at least 3 centimeters of water following a period
of stability or improvement is one of the two criteria
that can be used in meeting the VAP definition.
And then FI02 is the fraction of inspired oxygen, or the fraction
of oxygen in inspired gas.
So ambient air is 0.21.
The oxygen concentration there is 21%.
So we frequently talk about FI02 in percents,
even though that's actually the concentration.
So this is also as you know something that can be adjusted,
depending on the patient's oxygenation needs
on the ventilator.
And again, this is the other criterion.
So a sustained increase in the daily FI02
of at least 20 points, following a period of stability
or improvement is the other criterion that can be used
in meeting the VAP definition.
So go back and look at our VAP definition again.
Just to show you that it's either of these two criteria.
They do not have to meet both.
It's either FI02 or PEEP.
So here when we think about operationalizing surveillance,
for the vast majority of patients all we need to worry
about is the daily minimum PEEP and the daily minimum FI02.
You actually don't need to report any
of the other data elements unless you've identified a VAP.
So what we would do is basically for each day,
mechanical ventilation day, record the minimum PEEP
for that day and the minimum FI02.
So each day that number would be recorded in the table.
In this example, we have identified a two-day period
of stability here.
In this case, we're looking at the whole column there.
And we're going to focus really on the PEEP in this instance.
So on mechanical ventilation day s two and three, our PEEP is 5.
We can see then on mechanical ventilation days four
and five it goes up to 8.
So that's at least a 3 centimeter of water change.
And again,
you don't have to have it in both PEEP and FI02.
Just one or the other.
So here we have it for PEEP.
So this is a VAP event.
A ventilator associated condition.
The next thing that's important to talk
about is the date of the event.
So the date of onset of worsening oxygenation,
that's day one of that required at least two day period
of worsening oxygenation is the event date for VAE.
It's not the date on which all the VAE criteria are met.
So in this example, mechanical ventilation day four is the
first day of worsening oxygenation.
And that is our event date.
And that's important, because it's going
to define the timeframe within which we're going to look
for other criteria for this patient.
So again, the event date is important
because it defines what we call the VAE window period.
This is the period of days that we're going to focus
on for finding criteria to meet the other definitions.
For meeting I VAP, possible VAP, or probable VAP.
The criteria for those definitions have to be met
within that window period.
And the window period is defined by the event date.
It's also important
for detecting multiple VAEs in the same patient.
So we decided, again, in an attempt
to standardize the approach here,
that each VAE will be 14 days in duration.
Day one of that 14-day period is the event date.
So in an example, if June 1 is the date of onset
of worsening oxygenation in a VAP event,
and that VAP is reported, you could not detect
and report a second VAE until June 15, 14 days later.
In addition, you can't upgrade a VAE, say from VAP to I VAP,
based on data that are collected within that 14-day event period
but outside of the VAE window period.
So you're still looking in this VAE window period
to determine what kind of event you have.
That VAE window period which we're going to get
to is usually five days in length.
Anything outside of that, but still within that 14-day period,
you're not going to be able to use to upgrade your event.
And again, you can't report a new VAE
until that 14-day period has lapsed.
That's event date to event date.
So your baseline period of stability
or improvement may be occurring at the end of one 14-day period
and then you have your onset of worsening oxygenation on day 15.
So let's talk more about this VAE window period,
since I mentioned it a few times.
This is the period of days around the event date
which is again the day of onset of worsening oxygenation,
within which the other VAE criteria must be met.
It's usually five days, and it includes the two days before,
the day of, and the two days after the VAE event date.
And again, that is the first day of worsening oxygenation.
So this is a diagram of the VAE window period.
So the first row here is the first day
of mechanical ventilation.
The second row shows you the VAE day
where day 1 is the event date.
There is no day 0 in our event scheme, just keep that in mind.
There's no day 0.
And then you'll see that I listed in the other rows some
of the criteria that would need to be met for VAP, for I VAP,
and for possible and probable VAP.
The gray shaded area, including the yellow area is the
window period.
So it's the two days before the event date,
the VAE days minus 2 and minus 1.
The event day itself, which is VAE day 1, and the two days
after the event date, VAE days 2 and 3.
And so in this case, your temperature
or your white blood cell count abnormalities would have
to be met on any of those five days.
Your antimicrobial agent , your new agent,
would have to be started in that shaded period,
and then continued for at least four days.
Although that continuation can move outside of the window.
Has to be started in the window.
And then your purulent respiratory secretions,
your cultures that are positive, those things all have
to have been collected within that shaded period.
There is an exception.
There is always an exception.
This is a situation when the VAE window period is only three
or four days.
That can happen if the patient is very early in the course
of mechanical ventilation.
Remember we said that patients with VAE have to have been
on the ventilator for more than two calendar days,
the first two days of mechanical ventilation can be either a
baseline period so that they actually have their onset
of worsening oxygenation on day 3.
But they can't have their elevated temperature
or antimicrobial start on those first two days
of mechanical ventilation.
They can't have their positive culture collected
on those first two days and have it count towards a
VAE determination.
So in those cases, I'm going to show you this diagram again,
in this case, if you look at the mechanical ventilation row,
you'll see this patient is actually very early
in the course of mechanical ventilation.
So in this case, mechanical ventilations day one and two,
that's this patient's baseline period.
They really just went to the mechanical ventilation recently.
Mechanical ventilation day three is actually their event date
in this case.
That's their first day of worsening oxygenation.
And then they actually fulfill all
of their VAP criteria on day four.
In this case, because we can't use any of the criteria
on mechanical ventilation day one or two for I VAP
for possible or probable VAP, we have a three day window period.
So it's at event date and the two days after.
It's during that three day period that they would have
to have an abnormal temperature white count,
that they would have had to be started
on the new antimicrobial agent, and that they would have
to have had any respiratory specimens collected to be used
in meeting any of the other definitions.
And this is all outlined in the protocol as well.
So let's move on to I VAP.
I VAP has its challenges for sure.
So the first piece
of the definition is actually pretty straight forward.
We're all used to looking at temperatures and white counts.
In this case, we're just looking for a temperature outside
of the range indicated, so greater than 38 or less than 36,
or a white count greater or equal to 12,000 or less than
or equal to 4,000, or within that VAE window period.
So here to go back to this sort of operational plan,
we have a patient for whom we've been recording PEEP and FI02,
we identified a VAP event.
I've highlighted the baseline period, the day of the event,
and the two days after in yellow.
And it's showing you the event date.
But there's something wrong with this particular situation.
And that is that this is the situation we just talked about.
So this patient is very early in mechanical ventilation.
We can't actually use mechanical ventilation day two as part
of our ventilation period.
So now you'll see the four days highlighted in yellow,
the boxes indicating we have only one day before the onset
of worsening that we can use, we have the event day,
and then we have the two days after.
So this is an example of our window period
where it's actually a bit shorter.
And here, again, we're trying to minimize the amount of data
that have to be collected for any individual patients.
So we have a VAP event, which means we have to go forward
and look for the other criteria for the other definitions.
So here we would fill in the temperature
and white count information for this patient,
but just for the VAE window period
because that's all we're really concerned
with in meeting the surveillance definition.
And in fact, it may be so obvious that you don't have
to record all of this information.
They may have multiple temperatures
like this patient does, that would meet the definition.
And you just have to find one.
Having identified that abnormal temperature white count we have
to now go on and think
about whether a new antimicrobial agent was started,
and if it was continued for at least four calendar days.
I'm going to tell you that my personal opinion is
that this is the most complicated part
of this surveillance definition algorithm.
And I would just ask you to be patient.
I think it will eventually make sense to all
of you, and it's not perfect.
We have really tried to figure out a way to keep it as simple
as we can, and yet account for all of the things
that we know can exist in a critically ill patient
in the ICU with renal insufficiency
and everything else.
We're not requiring that you need to know the dosing
of the agent, what the patient's renal function is
or what the indication for therapy is.
We've tried to kind of define a standardized way
to do this that's not -- not too terribly complicated.
So the first step is figuring
out if a new antimicrobial agent has been given.
So we have defined a new agent.
It's any agent listed in the appendix of the protocol,
and I'll mention what those things are, that is initiated on
or after the third calendar day of mechanical ventilation
and in the VAE window period, which is the period, again,
defined most of the time by the two days after, the day of,
and the two days after VAE onset.
The agent is considered new if it was not given to the patient
on either of the two days preceding the current
start date.
The new agent has to have been continued
for at least four consecutive days.
But there's no requirement
that it can be the same antimicrobial agent give
on four consecutive days.
You could have a combination of agents that get you
to that required four days.
It has to have been administered IV, IM, via the digestive tract
or via the respiratory tract.
So things given intraperitoneally,
washings at the time of surgery, topical agents,
those things do not count.
So I just want to mention briefly what drugs are
in the appendix.
Again, this is on line, this hasn't changed,
so you can look at that.
It's on Page 20 of the VAE protocol that's posted.
It is a broad range of agents that could be used
to treat healthcare associated infections.
Mostly, it's anti bacterials, which you would expect.
There are anti fungals in there,
and there are a few anti virals in there as well.
There are also plenty of agents in there that would not be used
to treat a respiratory infection.
An example would be for patients on oral vancomycin,
that is still going to be something you would have
to think about for I VAP.
That's because when we're defining I VAP we're not saying
that it's an infection related to the respiratory tract.
It could be an infection with a primary source somewhere else.
We're not trying to say we know
where that infection is originating.
The drugs that are not included I think will make sense to you.
We're not including anti *** drugs or anti TB drugs,
drugs that are used to treat viral hepatitis
or *** virus infections or anti parasitics.
I think when you see the list it will make sense to you.
So after we figured out if we have a new agent we have
to figure out if at least four days of therapy have been given.
And this is where we introduce the term
of a qualifying antimicrobial day.
This is a day on which the patient was given a new agent
or an antimicrobial agent that was determined to be new
within the VAE period.
And you need four consecutive QAD's
to meet the anti microbial criterion
within that I VAP definition.
And those four QAD's have to start
within the VAE window period.
So I'm going to show a couple of examples here.
And we are going to have tools
that I hope will make this make more sense.
When we're thinking about a patient who's received the same
agent for a period of days, days that are between administrations
of a new antimicrobial agent can also count as QADs,
as long as there's a gap of no more than one calendar day
between administrations of the same drug.
So in this case example,
we see that the patient was given Levofloxacin.
The patient was given it on day one, we see that --
I'll just put this up here so you can look at it.
It was not given in the two previous days.
So there's no Levofloxacin on days minus to or minus one.
So it's new.
It was given on -- also on days three, five, and seven.
So every other day, which is something that could happen
in a patient with renal insufficiency in the ICU.
In this case, because it's the same drug given over this period
of time you can count the intervening days as QADs,
because there are gaps of no more than one calendar day
between administrations.
So in this case, we can count all of these days.
We have seven consecutive QADs in this case
that would obviously met our criterion.
By contrast, when we're dealing with different drugs,
days between administrations are not going to count.
So in this case, the patient got Levofloxacin
on VAE days minus two and minus one.
That's a new drug, because it wasn't given
in the days before day minus two.
Then nothing is given on VAE day one.
And then the patient gets a new antimicrobial agent,
Meropenem, on VAE day two.
There are not four consecutive QADs here,
because we cannot count VAE day one.
It's between administrations of two different drugs.
So in this case, I VAP could not be met.
So let's go back to our table.
So again, this is the patient
for whom we've identified an abnormal temperature.
I simplified the antibiotic data collection here just
for illustration purposes.
You can see this patient got no antibiotics
on vent days one, two, or three.
But they did get a new antimicrobial
that was continued, then,
for more than four consecutive calendar days after that.
So in this case, we do actually meet the I VAP definition.
So let's move on to possible and probable VAP.
And again, possible and probable VAP are making use of laboratory
and microbiological evidence.
So possible VAP, you have to have the purulent secretions
or a positive culture.
Probable, you have to have purulent secretions
and a positive culture, and it has to be a quantitative
or semi-quantitative culture, or you can meet one of the criteria
in the second box which will probably be much less
commonly used.
So what are purulent respiratory secretions.
They are largely defined just as they are current
in the current surveillance algorithm for pneumonia.
So we're looking at gram stain polymorphonuclear leukocyte
or PMN counts, and squamous epithelial cell counts.
In the presence of purulent secretions alone can be used
to meet the possible VAP definition or it can be used
in combination with the semi-quantitative
or a quantitative culture result,
meeting at appropriate thresholds
to meet the probable VAP definition.
So a question that we've gotten quite frequently
at this point is how do I relate my lab's semi-quantitative gram
standard reporting
to the quantitative thresholds in the algorithm.
So current in the algorithm, you have to have greater than
or equal to 25 PMNs for low power field, and less than
or equal to 10 squamous epis per low power field.
That defines purulence.
We know a lot of labs don't
report gram stains that way.
So the first step is really talk
to your laboratory manager or director.
He or she may be able to tell you what corresponds,
what quantitative range responds
to their semi-quantitative reporting.
If your lab does not have this information we are trying
to provide some guidance on this issue
so that people can still use these definitions
for their internal purposes.
What I've shown here is actually
from the clinical microbiology procedures hand book,
the most recent edition, and we're going
to just arbitrarily use this range for circumstances
where a laboratory just simply can't provide you
with more information.
So in this case, looking at these equivalencies here,
purulent respiratory secretions
for our surveillance purposes could be defined by a report
of heavy or 4 plus or greater than or where
to 25 neutrophils per low power field and a report of rare,
occasionally, few, one plus or two plus, or less than or equal
to 10 squamous epithelial cells per low power field.
And again, I would urge you here,
this is a recently evolving issue
that we've been grappling with.
Please just review the protocol in 2013
to make sure nothing has changed.
Hopefully it won't, but just make sure you have the most
updated protocol.
Let's talk a little bit about respiratory culture results.
So appropriate intratracheal types for the possible
and probable VAP definitions include sputum
and the tracheal aspirate, bronchoalveolar lavage,
protected intratracheal brushings,
lung tissue, and pleural fluid.
Excludeing certain culture results
as pathogens unless they're isolated from lung tissue
or from pleural fluid, those are the two exceptions.
So candida species are just a report of yeast
without further specification,
coagulative negative staph, enterococcus species.
These are excluded if they're cultured
from an endotracheal aspiration, sputum culture, B A L,
protected intratracheal brush.
We're also of course excludeing the types of culture results
that might be normal flora,
mixed respiratory flora, altered flora.
Kind of non-specific culture results.
In terms of positive culture result reporting,
we do have language in the protocol that talks
about qualitative versus semi-quantitative
versus quantitative culture results.
Qualitative results are just where the organism is identified
for you, but no quantity is assigned.
So it's just Staphorus, for example.
A semi-quantitative result is going
to give you an estimated quantity.
So it might be one plus, two plus, et cetera.
It might be rare, few, moderate, heavy.
And then quantitative, of course, is the exact quantity
of the organism expressed
in colony forming units in milliliter.
So just to make that clear.
So back to this question,
how do I relate my lab's semi-quantitative culture
reporting to the quantitative thresholds
that are in the algorithm.
So just as it is for VAP right now,
we have quantitative thresholds specified
for probable VAP in the VAE algorithm.
And they'll be -- they're the same.
We've not changed those.
So you have to have at least 10
to the fourth colony units per ML of an organism growing
in a B A L to meet the definition.
If your laboratory is using a semi-quantitative system, again,
the first step is to talk to your lab.
They might be able to tell you what the correlation is
between the quantitative range or threshold
and what their reporting system is.
If your lab doesn't have guidance on --
or further information on this issue, again,
this is a situation we're working
on providing guidance for.
For surveillance at this point we would assume
that if you have a result of moderate or heavy growth
or two plus, three plus, or four plus growth,
and that's for cultures of lung tissue, endotracheal aspirate,
B A L, protected intratracheal brush,
that would meet the probable VAP surveillance definition as long
as you have the purulent secretions to go with it.
And again, please just check the protocol in 2013
to make sure you have the most up-to-date one.
Probable VAP also allows for inclusion
of some non-culture based results.
That's that second red box in the algorithm.
We expect that this will probably be used infrequently,
but it may come up from time to time.
Here we've included pathogens
that may be identified frequently using
non-culture-based diagnostic testing,
that includes Legionella species as well as a list
of respiratory viruses.
So we purposely have been vague about the types
of diagnostic tests that would be included there
because of course the technology is changing all the time,
we don't want the protocol to become outdated
because we haven't included the latest and best diagnostic.
So there are examples within the protocol
and the frequently asked questions of the types
of diagnostic testing that a lab might do for these organisms.
And you can refer to that, but the language
and the algorithm itself is purposely a bit vague
on this point.
There are lots of other pathogens, including things
like mycoplasma and chlamydophila,
that are detected using non-culture based techniques.
We do not have those included in probable VAP criteria.
Again, we have purposely limited the other pathogens
to a few select things we want to be sure to capture.
Is it possible that that list could change over time?
Sure, it's possible.
But for right now we started with just a few things.
Histopathology results from lung biopsies can be used.
And I've just listed some of the criteria
that could be incorporated
in meeting the probable VAP definition.
That would include identification
of the abscess formation or foci, of consolidation
with intense neutrophils accumulation
of bronchials or alveoli.
That language is actually in the current VAP protocol.
Evidence of lung parenchyma invasion by fungi and evidence
of infection with viral pathogens.
So there's a few different histo-pathological findings
that could get you to a probable VAP determination.
So going back to our example here,
we already identified an I VAP, those are the only patients
that we really have to look
at the micro biological laboratory evidence for.
In this case, we have an endotracheal aspirate
from mechanical ventilation day three.
It's purulent, based on the criteria
that we've laid out in the protocol.
But it's growing Staphorus.
We're not told any quantity there,
semi-quantitative or other wise.
So in this case, this is a possible VAP.
Because we have the purulent secretions,
we have a positive culture,
but we don't have purulent secretions or a quantitative
or semi-quantitative culture.
Let's see if I can get this working again.
Okay, so probable VAP, again, requires the criteria
that I've been talking about.
I want to show you one more example here.
So in this case, we saw endotracheal aspirate
from mechanical ventilation day three, it's purulent,
and in this case, we said we have Staphorus,
but it's quantitative, so 10 to the 5th CFUs per ML.
So this is a probable VAP.
Because we have the purulent is secretions an we have a
quantitative culture meeting the thresholds outlined
in the protocol.
This is another example that would meet probable VAP.
Here we have a pleural fluid intratracheal for the purposes
of this discussion we'll assume that was obtained at the time
of arthrocentesis and not from an indwelling test tube,
and it's possible for Staphorus.
And that alone would be sufficient
to meet the probable VAP definition.
And again, you could use histopathology results
or legionella or viral diagnostic testing results
here too.
I want to say a few words about pathogen reporting.
Pathogens can be reported for possible VAP
and probable VAP according to the usual reporting methods
that are utilized in NHSN with the exception
of those excluded pathogens that I mentioned.
Pathogens are not reported for VAP or I VAP.
And I want to talk a little bit
about positive blood cultures too.
What do we do with positive blood cultures that occur
around the same time as a VAE?
So I know you've gone through definitions
for secondary blood stream infection,
that's a culture confirmed BSI associated with a documented HAI
at another site that meets CDC surveillance definitions.
For VAE, you can report a secondary BSI again
for possible VAP and for probable VAP
when at least one organism cultured
from the blood culture matches an organism
from an appropriate respiratory tract intratracheal
that was collected during the VAE window period.
We do say that that blood culture just has
to have been collected in the 14-day event period.
Blood culture is not a criterion for a VAE.
So we're not requiring that it be collected during the
window period.
But it does have to be collected during the event period,
that 14-day event period, in order for you
to report it as a secondary BSI.
Just as with pathogens,
secondary BSIs are not reported for VAP or I VAP.
And I should mention to you there
in that second bullet you can't report a secondary BSI
for a possible or probable VAP
if a respiratory culture was not performed.
So if you have a possible VAP that's met
with purulent respiratory secretions alone,
there's no culture or the culture was negative,
you can't call a secondary BSI in that instance.
If you have a probable VAP that was met
with a histopathology criterion, again, you're not going
to be able to report that secondary BSI.
So just a few key things to remember
about numerator data collection.
For most patients you're only going to be worrying
about collecting the daily minimum PEEP and FI02
on the ventilator, nothing else, for most patients.
You only need to assess the temperature
and the white blood cell count information for patients
who fulfill that criteria, and then you only need to look
at those values during the three to five day VAE window period.
You only need to look at the antimicrobial administrations
for patients who have VAP
and an abnormal temperature or white count.
And again you're focusing
on identifying new microbial agents during that three
to five day VAE window period.
So as you move on you're kind of winnowing down the number
of patients that you need to collect this information for.
And then lastly, of course, you only need to look
at the laboratory, the microbiology
or the pathology data for patients who have met I VAP.
And again, just those specimens
that would have been collected during the window period.
So I want
to say a few words about denominators.
Ventilator days and patient days, just as usually,
are used for denominators.
You're going to collect the data daily at the same time each day.
We've done nothing to change the way
in which ventilator data are collected.
Your daily counts will be summed and the total
for the month will be reported in NHSN.
Again, ventilator days is the number of patients
in your chosen location who are managed
with a ventilatory device, and we have decided at least
at this point because we don't have evidence
to suggest we should be excluding them,
that you will just be counting all ventilator days.
You're not going to be worrying about patients who haven't been
on the vent long enough to have a VAE, you're not going
to be worried about excluding vent days for patients
on our excluded therapies or in the case
where you have pediatric patient housed in an adult location.
For right now you're just counting all
of your ventilator days.
And we are asking that you indicate for us the number
of patients on APRV if you have patients
like that in your units.
Again, because we feel like we need to get a better handle
on how common this is to know if we need to be thinking
about changing our criteria.
Again, your patient days, as you all know, number of patients
in your chosen location.
So this is the denominator form.
And the only difference you'll see here
in the ventilator column is that it's split in two now.
So we ask for the total patients on a ventilator,
and the number on APRV.
And maybe for many of you that will be zero all the time.
But there may be some units or some facilities that use it
on occasion or even a fair amount.
So just want to make sure you record that.
And then for analysis purposes, which I'm really not going
to talk very much about today, your rate is going
to be your total number of VAEs divided by your ventilator days,
and your ventilator utilization ratio will be calculated
like it always has been.
So just to reiterate some of the tips for getting started,
do get familiar with that protocol,
do try to review those FAQs, we will try to add to those
as we get more questions
and develop more guidance for folks to use.
Again, I think establishing or enhancing existing relationships
with your respiratory therapists
and critical care colleagues is really important.
There may be ways that they can help you collect these data
or organize these data or track these data,
depending on your individual circumstances.
And you may want to ask them about whether you use
or they use any of these other therapies,
like high frequency ventilation or extra corporeal support,
or APRV, are those things that are used in any of the units
in your facility, so you can have that awareness
when you're going in to do surveillance.
Again, determining your lab's approach to gram stain
and culture result reporting, and then I want
to talk a little bit about using tools for data collection
and for learning the definitions
and making the VAE determinations.
So these are not up on the web yet,
but we hope they will be soon.
So we have two forms.
One is -- this is just a screen shot,
I know you can't really use it.
But we have a ventilator associated event data collection
tool that is basically a table like I've been showing you.
There will be a column for each of the criteria.
Use one of these forms per patient.
I think there's enough for a little over two weeks
of mechanical ventilation days on this form.
And you can use this to basically track your data
and make your determinations.
So that's one thing we hope to make available.
There's another work sheet to help sort
out the antimicrobial use piece, because as I mentioned
that may be the more complicated piece to figure out.
At least initially until you're used to it.
So this will be up on the web as well.
There are instructions that go with this that walk you
through it, so you can figure out this whole qualifying
in a microball day concept and how to determine whether
that criterion has been met.
And lastly, we are working on a VAE calculator,
so we're very fortunate that our information technology
colleagues have been developing this.
This will be a tool that will be available on line,
that you'll be able to enter data into.
It doesn't store or submit any data, it is just a tool for you
to kind of play around with.
You can get VAE determinations using this tool,
it can help you learn the algorithm,
there are explanations provided, and I think we may have time,
I can actually do a brief demo of this.
So I think this is something that will be very helpful
and we will make it available.
So some key take-home points.
The patient has to be ventilated for more than two calendar days,
that's the key difference from the current approach.
They have to have this at least two day --
calendar day period of stability or improvement followed
by two calendar days of worsening in oxygenation.
The earliest day that a VAE can have its onset is day three
of mechanical ventilation.
The first day that all the VAP criteria can actually be
fulfilled is mechanical ventilation day four.
The event date defines the VAE window period.
Usually again, it's two days before, the day of,
and two days after the event date.
So five days.
But it could be shorter if that worsening
of oxygenation is occurring early in the course
of mechanical ventilation.
So in those cases, it might be three days,
it might be four days.
Just be aware of that.
All of the other criteria for I VAP, for possible VAP,
and probable VAP have to be identified
within that VAE window period.
And the VAE clock will start over again
when the patient begins a new episode
of mechanical ventilation, when a new vent period starts,
or when the patient comes off of an excluded therapy.
So again, remember, they're not eligible for VAE surveillance
if they're on the high frequency ventilation or ECMO.
Once they come off, you start the process of looking
for those changes in PEEP and FI02 on mechanical ventilation.
So I just want to acknowledge lots and lots of people
who have participated in this process over the past few years,
it's been a real group effort.
And I will thank you.
My e-mail is there, if you have questions feel free
to e-mail me.
Before I stop for questions I do want
to show you this calculator.
Okay. So this is our VAE calculator.
It is not yet on the NHSN web site, but we hope it will be
in the not too distant future.
So the first thing you'll do here,
there's a little calendar icon,
the first thing you do is you enter the date of initiation
of mechanical ventilation.
So I'm going to pick an arbitrary date.
This is October.
Let's go back to September.
I'm going to pick September 15.
The next thing you do is you're going to enter the period
of interest , the period of days you want to look
at and enter data for.
We did this because some patients are
on mechanical ventilation for a really long period of time.
So we wanted to give the option in those patients
of not having three months worth
of days displayed in the calculator.
So hopefully this will make sense when you look at it.
So in this case, let's say you want to look
at September 25 through October 23.
So what it does then is it pulls up a table
with all of our dates in it.
And it tells
us to enter our PEEP and our FI02 values.
So I can just go through and enter --
let's just do five all the way down here.
I don't even have to enter all of these days here.
Okay, so I could even stop there.
And I'll hit the calculate VAP button.
And it will highlight the event for me.
And you'll see the event day,
that's where the yellow VAP box is.
So that will allow you to see the VAE window period.
And it will also change that window period.
I won't show you this, but if you are entering something early
in the course of mechanical ventilation,
it won't highlight the first couple of days.
So if you have a shorter window period it will reflect that.
So now I have a VAP, I know I have to look for I VAP.
So I click the go to I VAP button.
And again there's some explanation at the top here
to tell me what I need to do.
But here you'll see I have a column for the temperature,
I have a column for the white count,
and here I don't enter the actual temperature
of white count.
I'm just checking a box to say yes, I have this criterion.
So in this case let's say yeah, we have a temperature outside
of the range on this day.
That's all we need.
And it will allow you to enter anti microbial too.
So there's a big long list of anti microbials
that reflect what's in the appendix.
I can pick a drug, and in this case,
let's say we've got five days of therapy here started
within the window period.
So you can add drugs, you can remove drugs.
So lots of these patients may be on multiple antibiotics.
You can add multiple drugs.
Then I'll calculate I VAC.
It changes this to I VAC now,
because I actually met the definition,
and it highlights my qualifying anti microbial days for me here.
So you can see how that would work.
Once I get to this point you can also actually hide --
this gets to be a pretty big table.
You can actually hide the FI02 if you want,
just to keep things all in one screen.
Then I can go to VAP.
And this is the part
of the algorithm that's still being worked on.
So this may end up looking different than it does now.
But basically, the criteria are listed here,
and I would just pick whatever I had during the VAE
window period.
It tells you the date range you have to look for,
and then I would calculate it
and at the top it says this conforms
to a possible VAP definition.
So again, this piece of it we're still working
on the VAP piece of it.
So that's still -- still in process.
And then you can start over again, it erases everything
and resets it totally.
Just be aware of that.
You can't actually download data or store it -- [Applause] --
and I just want to give credit
to Barry Rhodes in our group
who has developed this, because he's done an amazing job.
And now I'm happy to take questions.
It's not on.
[ Background sounds ]
>> Can I go ahead and go then?
>> Sure. Yeah.
Go ahead.
>> If somebody dies after three days,
and so they don't have the four days
of anti microbial therapy, they can't have a --
>> That's correct.
Yup.
>> So maybe my mind's not transitioning yet,
but where does aspiration
and trauma prior to admission fit in?
>> So those circumstances won't be specifically addressed
or considered.
I think a lot of it will --
will actually be addressed in this requirement for a period
of stability and a requirement that, you know,
those first couple of days
of mechanical ventilation aren't going
to count for the other events.
So I hear what you're saying.
This is intentionally capturing a broader range of events.
It's not just going to be VAP, obviously.
So there will be other things that come into the mix there.
And I do hope that that baseline period will largely address
those kinds of difficult situations
that I know sometimes cause issues
with the current definitions.
>> All right.
Thank you.
>> Sure.
>> Hi. We have some questions.
The first being what if there is a prior positive respiratory
culture before the two days,
before or after the worsening oxygenation?
>> All right.
So for practical reasons, for practical reasons
for the temperature, the white count,
for the cultures you're only looking in the window period.
So it is entirely possible
that a patient had a previous positive culture
or maybe they've been having fevers every day.
But as you know, it's very difficult
to define what an important change
in temperature is for patients.
I mean, practically, I just don't think
that would work for most folks.
So for that and the culture we just said, you know,
we know it's not perfect.
But you're just looking in that window period,
you're not thinking about stuff that was outside of that.
>> The other question was we know that ECMO
and high flow is excluded.
What about patients who are
on oscillators, is that considered --
>> Right, so high frequency oscillatory ventilation,
those patients would be excluded.
Yup.
>> Thank you.
>> Sure.
>> Very nice talk, Dr. Magill thank you.
I noticed you kind of breezed through the analysis slide,
and it looked like you were going to do an aggregate
of ventilator associated events as the numerator.
But there will be an ability to break that down
for the possible and probable VAP?
Because of course the Intensities will be most
interested in those?
>> Yeah. So the analysis function --
the things you'll be able to do
with your own data we'll be working on.
And the plan is to allow you to break it
down by specific site as well as overall.
>> Great. Thank you.
>> So in the past when I had a positive blood culture
and the patient had a central line and was on a ventilator,
that blood culture would put them into pneumonia 2.
So now if that blood culture does not relate --
if they had a sputum or an ET aspirate, it was a non issue.
Now that blood culture will have to match the sputum in order
to relate it to pneumonia.
Otherwise I would have to call it a class C?
>> That's right.
Yeah. And -- sure.
So the question is that, you know, the blood culture
for the current VAP definitions is part
of the pneumonia 2 definition.
So if you have that positive blood culture it can be
incorporated as part of a pneumonia determination,
the secondary BSI box checked.
Current, with VAE once that's implemented, unless you have
that matching positive respiratory culture you're not
going to be able to call the secondary blood
stream infection.
So there may be instances
where patients have a positive blood culture with one organism,
possible or probable VAP, due to a different organism isolated
from a respiratory intratracheal,
and that positive blood culture could end up needing
to be reported as a [Inaudible], for example.
That may indeed happen.
It's not -- yeah, it's not on.
Sorry.
>> Is this one on?
>> Yes, that's on.
>> My question has to do with the use of APRB.
And if you have a patient that had a PEEP of 5
and their FI02 was 60, and then the surgeon switches them
over to the A P R V, I understand
that then you're just monitoring the FI02.
But when the patient goes back on to system control
and they have a PEEP, is
that people considered, then, an event, or --
>> So --
>> -- because there was no PEEP on the APRB?
>> Sure. So you'll be able to use FI02 throughout, right?
So you could still look for changes
in that regardless of the mode.
With PEEP, once they're back on conventional you basically kind
of be starting from baseline with that.
So you still have to establish that baseline period for PEEP.
So FI02 is going to keep going, but your [Inaudible] --
>> But that addition of the PEEP is not the event.
So then if it were 5 and 5 and the next day it's 10,
that would be the event?
>> Yes.
>> I have one more question.
The period of stability, it's hard for me to consider, like,
if somebody is -- their PEEP is 5, but their FI02 is 80 or 90,
but they're stable with that for several days, is that stable?
>> So stability is all relative to worsening and vice versa.
So we're not asking really for you
to make a clinical judgment about stability.
It's purely based on the numbers.
So in that case, you know,
if you have a patient requiring a very high level of FI02,
there's not really much higher they can go at that point.
But if their people were to increase by that --
you know, someone were to say we need to crank up the PEEP,
you could be using that to identify your VAP
or your VAE at that point.
>> So I can consider them stable with an --
>> That's correct.
As long as that number has been stable
for the two days proceeding the period of worsening,
and the worsening meets the threshold, then yes.
Yup.
>> I've been using this for about the last 15 months,
and it's -- I still learned some stuff here today
about the antibiotics, [Inaudible] it's an awesome way
to [Inaudible] end up calling it.
So I just want to say for anybody that feels frightened
about it, you're going to love it when you [Inaudible] --
>> Thank you for that feedback, appreciate it.
>> Thank you.
I also agree with the lady who just said that --
I have been doing a parallel
since the beginning of this year as well.
And found this is much less interpretive and a lot easier
to follow than looking at the chest x-rays.
And you can tell when one radiologist ends
and the next radiologist starts.
So@so this is great.
And it's a nice way to get the interpretation
out of the equation.
I did want to ask a question, because I didn't see
in the definitions that I was using before
about the second occurrence of VAP.
And is there any differentiation, is it not on?
Sorry. Sorry.
Is there any differentiation when you cross
over into the next month or is it just, you know,
the second occurrence has to wait the time period?
>> Yeah. It's just based on the 14 days,
so it wouldn't make a difference.
You know, that month distinction is not going to factor into it.
It could cross over, so if your 14-day period started at the end
of one month isn't going to go into the beginning of the next.
And --
>> As long as it's in the same vent period?
>> That's correct.
Yup.
>> And also the spontaneous trials sometimes are
for one day.
So that is a new thing that I guess we'll have to take
into consideration, if there's a whole day off
for spontaneous trial then they're back on.
>> Yeah. So -- if you have questions
about that, certainly e-mail me.
We have gotten a few questions.
I think that again hopefully working off
of that daily minimum and requiring
that it be a sustained change.
Hopefully, that will minimize the circumstances where,
you know, those kinds of sort
of weaning activities are playing a role
in a VAP determination.
But I'm happy to talk with you more about that.
>> Great. And one more thing, I'm sorry.
You know, sometimes when you were going over the antibiotics
and stuff, you can see the purpose
for the antibiotics sometimes.
My concern would be when they're doing the Noxil
for a [Inaudible] infection as opposed
to like an aspiration pneumonia.
But it sounds like that's okay, I VAP,
and I guess it can bring it to our medical staff,
our [Inaudible] physicians were concerned
that infection could be anything.
I guess I VAC means infection doesn't need to be respiratory?
>> That's right.
Yeah. I know that's --
that's sometimes a difficult concept to kind of take in.
But that is really what the working group intended
with that, to not be implying
that things were a respiratory origin within that definition.
I think we do have a lot to learn about I VAP.
I think this first year will be very helpful
in understanding how people are implementing it,
the challenges they're facing, and what we might do
to make it better in the future.
>> Great. Thank you for your presentation.
>> Sure. Thanks.
>> Thank you.
I have a couple of questions.
Since the [Inaudible] conference,
my group has been working on the surveillance piece,
and how we're going to make that work.
We have hospitals with multiple ICUs, multiple --
I mean, lots of patients on ventilators.
So is the expectation that we are following every patient
every day, and how do you -- how do we accomplish this?
>> So -- so if you decide you're going to do VAE surveillance
and you may decide to start it in one unit or multiple units,
depending on what circumstances are in your facility
or your state or your region.
The intent is for the surveillance to be done
in the same kind of prospective way
that you do surveillance for the other things.
Now obviously, we're talking about daily minimum values.
So you're going to have to look back at the previous day
to know what those were.
It's a calendar day.
It's not just a 24 hour period, so it's one calendar day,
June 1, June 2, et cetera.
So for those daily minimums you're effectively going
to be the next day looking at them.
And then assessing again for those periods of change.
And again, you're not --
you're not in a position of collecting all
of the entire algorithms data for every patient.
You want to wait until you found that VAP event to go on
and collect the other information.
So I think it can seem daunting, if you think about of the number
of different systems you might have to be accessing
to get this information.
I know ventilator data might not be something
that everyone's real familiar looking at.
That's again why I think interacting
with respiratory therapy in critical care is important
because they are used to looking at that,
and I think they can help you in many cases.
But I think, you know, having that table, whether, you know,
some facilities could do it electronically,
some might just have something at the bed side.
Others might have a table they carry around with them.
I think those will help make it smoother for people.
>> Okay. The other question I have was is there plan
to pilot this in any hospitals or has that been done already?
>> So again, we did base a lot of this algorithm on work
that Mike Klompas has done.
So he, you know, has experience applying these algorithms
in the places he's worked with.
We are hoping to field test it.
Time-wise, that's probably going to be in parallel
with when it's actually available for use.
But we are hoping to do that.
>> Thank you.
>> One of my hospitals just texted me this question.
So that's where it's coming from.
Can you ask -- let's see.
What if all criteria is met
but the chest x-ray says normal respiratory flora
with heavy growth of MRSA?
Wouldn't make any difference, would it?
>> I'm sorry.
Can you repeat that, chest x-ray -- culture?
>> Culture.
Sorry. Yeah.
Old eyes.
>> Culture shows --
>> The culture says normal respiratory flora
with heavy growth of MRSA.
>> So you can use that, and actually I think --
I think one of your cases has that example.
So you can use the Staphorus as part of that.
It's just, you know, if all you had was normal flora you can't
use it.
>> Thank you.
>> Sure. Any other questions?
>> Thank you, Shelly.
That was fantastic.
[Applause]