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Objective Outcomes
Michael Klompas MD, MPH, FRCPC, FIDSA
Harvard Medical School, Harvard Pilgrim Health Care Institute, and
Brigham and Women’s Hospital, Boston, USA
CUSP for Mechanically Ventilated Patients
October 7, 2014
What are they?
Why do they matter?
Disclosures
Grant funding from the US Centers for Disease Control and Prevention
Honoraria from Premier Healthcare Alliance for lectures on VAP surveillance
Ventilator-associated pneumonia
Affects ~5-10% of ventilated patients
Increases ICU length of stay by ~4-7 days
Increases hospital length of stay by ~14 days
Crude mortality rate 30-50%
Attributable mortality 8-12%
Adds ~$10-50,000 to cost of hospital stay
CMS 1533-P, 2007Safdar et al, Crit Care Med 2005; 33:2184
Tejerina et al, J Crit Care 2006; 21:56 Muscedere et al, J Crit Care 2008;23:5-10
Eber et al, Arch Intern Med 2010;170:347-353Nguile-Makao et al, Intensive Care Med 2010;36:781-9
Beyersmann et al, Infect Control Hosp Epidemiol 2006;27:493
Diagnostic Criteria for VAP
High Temp
Low Temp
High WBC
Low WBC
Low P:F Ratio
Increased vent settings
Purulent secretions
Gram stain neutrophils
New AntibioticStart
Infiltrate
CDC Old Definition ✓ ✓ ✓ ✓ ✓ ✓ ✓CDC New Definition ✓ ✓ ✓ ✓ ✓ ✓ ✓HELICS Criteria ✓ ✓ ✓ ✓ ✓ACCP Criteria ✓ ✓ ✓ ✓ ✓Clinical Pulmonary Infection Score ✓ ✓ ✓ ✓ ✓ ✓ ✓Johanson’s Criteria ✓ ✓ ✓ ✓
Ego et al. Chest 2014;ePub ahead of print
Impact of Diagnostic Criteria on VAP Prevalence
CDC Old
Criter
ia
CDC New
Crit
eria
HELICS
ACCPCPIS
Joha
nson
0
10
20
30
40
Nu
mb
er o
f V
AP
sProspective surveillance, 1824 patients, Tertiary Med-Surg Unit, Belgium
Ego et al. Chest 2014;ePub ahead of print
All VAP Signs Subjective, Non-Specific, or Both
The core clinical signs associated with VAP:
• Radiographic opacities• Fever• Abnormal white blood cell count• Impaired oxygenation• Increased pulmonary secretions
Interobserver agreement in VAP surveillance
7
IP 1 (11 VAPs)
IP 2(20 VAPs)3
30
1 7
5
IP 3 (15 VAPs)
Klompas, AJIC 2010:38:237Kappa = 0.40
50 ventilated patients with respiratory deterioration
6 Case Vignettes Presented to 43 Surveyors
0
1
2
3
4
5
6
Survey Respondents
Nu
mb
er o
f V
AP
s
Crit Care Med 2014;42:497
Accuracy of clinical diagnosis of VAPRelative to 253 autopsies
80%
100%
Sen
sit
ivit
y /
P
osit
ive P
red
icti
ve V
alu
e
60%
40%
20%
0%PositivePredictiv
eValue
Tejerina et al., J Critical Care 2010;25:62
Sensitivity
Loose definition:Infiltrate and 2 of temp / wbc / purulence
Strict definition:Infiltrate and 3 of temp / wbc / purulence
Accuracy of quantitative BAL culturesRelative to histology
80%
100%
Sen
sit
ivit
y /
P
osit
ive P
red
icti
ve V
alu
e
60%
40%
20%
0%PositivePredictiv
eValue
Kirtland, Chest 1997;112:445Fabregas, Thorax 1999;54:867
Chastre, Am Rev Respir Dis 1984;130:924Torres, Am J Resp Crit Care Med 1994;149:324
Marquette, Am J Resp Crit Care Med 1995;151:1878Papazian, Am J Resp Crit Care Med 1995;152:1982
Sensitivity
Implications for prevention
from doctorrw.blogspot.com
The VAP Prevention Paradox
VAPRate
s
Vent
LOS
ICULOS
Hospital
LOS
Death
Regular oral care with chlorhexidine
Silver-coated endotracheal tubes
Head-of-bed elevation
Crit Care 2009;13:315
VAP diagnosis is subjective
VAP diagnosis is non-specific
Many VAP studies under-powered
Reasons for the Prevention Paradox
The case of chlorhexidine
The case of silver-coated ETTs
The case of head of bed elevation
VAP diagnosis is subjective
VAP diagnosis is non-specific
Many VAP studies under-powered
Reasons for the Prevention Paradox
The case of chlorhexidine
The case of silver-coated ETTs
The case of head of bed elevation
Oral CHG in Non-Cardiac Surgery Patients
Open Label Studies: RR 0.61 (0.35-1.04)
Double-Blind Studies: RR 0.88 (0.66-1.16)
JAMA Internal Med 2014;174:751
Routine Oral Care with Chlorhexidine
Impact on mean duration of mechanical ventilation:
NONE
Impact on ICU length-of-stay
NONE
Impact on mortality
POSSIBLE INCREASE!!! RR 1.13 (0.99 to 1.28)
JAMA Internal Med 2014;174:751
VAP diagnosis is subjective
VAP diagnosis is non-specific
Many VAP studies under-powered
Reasons for the Prevention Paradox
The case of chlorhexidine
The case of silver-coated ETTs
The case of head of bed elevation
Silver-Coated Endotracheal TubesVAP Rates and Outcomes
VAP Incidence
VA
Ps p
er
100 P
ati
en
ts
4.0
5.0
3.0
2.0
1.0
0
8.0
10.0
6.0
2.0
0
4.0
Conventional ETTs
Silver coated ETTs
Len
gth
s o
f S
tay (
days)
Ventdays
ICUdays
Hospital
days
6.0 12.0
JAMA 2008;300:805
Silver-coated endotracheal tubesMicrobiological Outcomes
VAP Counts Included: yeast, normal flora, coag-neg Staph, & Enterococcus
VAP diagnosis is subjective
VAP diagnosis is non-specific
Many VAP studies under-powered
Reasons for the Prevention Paradox
The case of chlorhexidine
The case of silver-coated ETTs
The case of head of bed elevation
Reducing the risk of ventilator-acquired pneumonia through head of bed elevation Nursing Crit Care 2007;12:287
N=221
N=86
N=30
78% in VAP, P=.04
71% in VAP, P>.10
46% in VAP, P>.10
Semi-recumbent position and ICU Days
-2 -1 +1 +20
Drakulovic, Lancet 1999(difference in means)
van Nieuwenhoven, CCM 2006(difference in medians)
Keeley, Nursing Crit Care 2007(not reported)
Difference in ICU Length of Stay
Favors Semi-Recumbent
Position
Favors SupinePosition
???All studies
Critical Care Medicine 2013;41:2467-2475
Ventilator-associated conditions (VAC)
DatePEEP(min)
FiO2(min)
Jan 1 10 100
Jan 2 5 50
Jan 3 5 40
Jan 4 5 40
Jan 5 8 60
Jan 6 8 50
Jan 7 8 40
Jan 8 5 40
Jan 9 5 40
VAC
Rise in daily minimum PEEP ≥3cm or FiO2 ≥20 sustained ≥2 days after ≥2 days of stable or improving daily minimum PEEP or FiO2
http://www.cdc.gov/nhsn/VAE-calculator
Impact of VAEs on length-of-stayControlled for time to VAE, age, sex, unit, comorbidities, severity of illness. All comparisons are to patients without VAE (control).
Hospital Days
Ventilator Days
0 5 10 15 20 25 30 35
ControlVAC ***
IVAC ***Possible VAP ***Probable VAP ***
ControlVAC ***
IVAC ***Possible VAP ***Probable VAP ***
Days
Infect Control Hosp Epidemiol 2014;5:502-510
Impact of VAEs on mortality
Odds Ratio or Hazard Ratio1 10520.
5
USA – 3 centersPLoS ONE 2011;6:e18062
USA – 8 centersCrit Care Med 2012;40:3154
Canada – 11 centersChest 2013;144:1453
Netherlands – 2 centersAm J Resp Crit Care Med 2014;189:947
USA – 2 centersCrit Care Med 2014;ePub
USA – 1 centerInfect Control Hosp Epidemiol 2014;5:502
VAE VAP
Canadian Critical Care Trials Group ABATE StudyEnhanced care for vented patients, 11 ICUs, 1330 patients
Muscedere et al. Chest 2013;144:1453-1460
Baseline 6 months 15 months 24 months0
4
8
12
16VAC Rate (trend P=.05)
VA
Cs
per
100
pat
ien
ts
Conservative Fluid Management
• 304 patients randomized to daily BNP levels versus usual care
• Patients randomized to daily BNP levels• More diuretics, negative fluid balance• Less time to extubation• 50% fewer VAEs
P=.02
Dessap et al. Chest 2014; ePub ahead of print
Daily BNPs
Usual Care
0% 2% 4% 6% 8% 10% 12% 14% 16% 18% 20%
Incidence of VAEs
The VAP Prevention Paradox
VAPRate
s
Vent
LOS
ICULOS
Hospital
LOS
Death VAEs
Regular oral care with chlorhexidine ?Silver-coated endotracheal tubes ?Head-of-bed elevation ?
Crit Care 2009;13:315
The Upshot
VAP rates are unreliable outcomes
VAE rates likely reliable but still very new. Unclear how best practices will impact them.
If we want to know whether a prevention measure really works or not, we have to look at objective outcomes such as:
duration of mechanical ventilation
ICU length-of-stay
hospital length-of-stay
mortality
Minimize sedationGreater sedation associated with longer ventilator and ICU stays. Increases risk for pneumonia and other infections.
RCT data from Denmark showing that vented patients can be adequately managed with NO sedation
Spontaneous awakening trials associated with less overall sedative use and earlier extubation
http://ppcdrugs.com/en/products/alphabetical/midazolam-1mg-5ml/
NEJM 1996;335:1864-9 NEJM 2000;342:1471-7Lancet 2008;371:126-134 Lancet 2010;375:475-80
Paired daily sedative interruptions and spontaneous breathing trials
Spontaneous breathing trials associated with earlier extubation
Patients are more likely to pass spontaneous breathing trials if they’re awake for the trial
RCT data showing that pairing SATs with SBTs speeds extubation by ~3 days and shortens ICU and hospital LOS by ~4 days compared to SBTs alone
Lancet 2008;371:126-134NEJM 1996;335:1864-9
Wake Up and Breathe
Early mobility – Wake Up & Walk!
Early mobilization assocaited with less time to extubation and shorter ICU stays
May also help prevent atelectasis & delirium
As with improved sedative management and weaning protocols, less time on vent means less time at risk for VAEs
http://69.36.35.38/images/CHESTPhysician/CritCareCom0610Fig2.jpg
Lord et al., Crit Care Med 2013;41:717Schweickert et al., Lancet 2009;373:1874
Needham et al., Arch Phys Med Rehabil 2010;91:536
Low tidal volume ventilation
Higher tidal volumes associated with acute lung injury
Randomized controlled trial data showing that lower tidal volumes protect against acute lung injury in patients without ARDS and lower mortality rates in patients with ARDS
Determann, Critical care 2010;14(1):R1ARDSnet, NEJM 2000;342:1301-1308
http://page2anesthesiology.org/2012/less-rather-than-more-volume-is-better-when-ventilating-patients-after-cardiac-surgery/
Summary
VAP diagnosis is subjective and non-specific
Inconsistent association between VAP and patient outcomes
Many interventions purportedly lower VAP rates but no impact on patient outcomes: “the VAP Prevention Paradox”.
Makes VAP an unreliable outcome
VAEs more objective and consistently predict adverse outcomes… but the definitions are still very new, very little data so far on how prevention strategies impact VAE rates
Implication: need to look at objective outcomes if we want to be sure that CUSP 4 MVP is helping our patients
Am J Resp Crit Care Med 2014;8:947Chest 2014;ePub ahead of print