CUSP for VAP: EVAP
On Boarding Call #5: Evidence Review
Sean Berenholtz M.D., MHS
Nishi Rawat, M.D.
September 18th, 2012
2:00 pm EST/ 11:00 am PST
On Boarding Call Schedule –
Tuesdays 8/21–9/25 @ 2:00
2
Presentation Objectives
To review the evidence to support the
implementation of:
• Head of Bed Elevation (HOB) ≥ 30 degrees
• Spontaneous Awakening and Breathing Trials
(SAT & SBT)
• Oral Care with Chlorhexidine
• Subglottic Suctioning
3
What data will teams need to collect?
• Monthly VAE data using new CDC NHSN definitions
– Numerator and denominator
– Will work with you to collect baseline ‘VAE’ data
• Daily process measure data
• Quarterly implementation data and semi-annual
structural measures
– Brief survey and structured interview
• Annual teamwork/culture data using the AHRQ
Hospital Survey of Patient Safety (HSOPS)
• Will work with HENS to ensure data reporting meets
their needs
4
Process measures: Daily evaluation
1.
Head of Bed Elevation (HOB)
a.
2.
Spontaneous Awakening and Breathing Trials (SAT & SBT)
a.
3.
At least 6 times per day
Oral Care with Chlorhexidine
a.
5.
Make a daily assessment of readiness to wean with the use of the SAT and
SBT.
Oral Care
a.
4.
Use of a semi-recumbent position ( ≥ 30 degrees).
Should be included in the oral care regimen 2 times per day
Subglottic Suctioning
a.
Use subglottic suctioning ETTs in patients expected to be mechanically
ventilated for >72 hours
5
Policy Based Structural
Measures :
1.
2.
3.
4.
5.
Use a closed ETT suctioning system
Change close suctioning catheters only as needed
Change ventilator circuits only if damaged or soiled
Change HME every 5-7 days and as clinically indicated
Provide easy access to NIVV equipment and institute
protocols to promote use
6. Periodically remove condensate from circuits, keeping the
circuit closed during the removal, taking precautions not to
allow condensate to drain toward patient
7. Use early mobility protocol
ETT endotrachael tube; HME heat moist exchanger; NIVV non-invasive ventilation
6
Policy Based Structural
Measures :
8. Perform hand hygiene
9. Avoid supine position
10. Use standard precautions while suctioning respiratory tract
secretions
11. Use orotracheal intubation instead of nasotracheal
12. Avoid use of prophylactic systemic antimicrobials
13. Avoid non-essential tracheal suctioning
14. Avoid gastric over-distention
ETT endotrachael tube; HME heat moist exchanger; NIVV non-invasive ventilation
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Head of Bed Elevation
8
Head of Bed Elevation :
VAP Prevention Guidelines
• Recommends head of bed elevation at an angle of
30–45 degrees for patients with a high risk for
aspiration (e.g., a person receiving mechanically
assisted ventilation) in the absence of medical
contraindication.
• CDC; MMWR Recomm Rep. 2004;53:1-36
• Recommends that patients should be kept in a semirecumbent position (30-45 degrees) rather than
supine to prevent aspiration.
• ATS/IDSA; AJRCCM 2005;171(4):388-416.
9
Head of Bed Elevation :
VAP Prevention Guidelines
• Recommends the head of bed elevation to be 45 degrees,
as long as not contraindicated.
• Canadian VAP Prevention Guidelines; J Crit Care
2008;23(1):138-147.
• Recommends the use semi-recumbent position (30-45
degrees) as a strategy to prevent aspiration.
• SHEA; ICHE 2008;29:S31-S40.
10
HOB elevation: 2009 Meta-Analysis
• 3 RCTs evaluating 337 patients receiving
mechanical ventilation
• Randomized to semi-recumbent 45 degrees
or supine position
• Odds of developing VAP significantly lower
among patients positioned semi-recumbently
– OR ,0.47,95% CI, 0.27-0.82
Alexiou J Crit Care 2009; 24(4):515-522
11
HOB Elevation: 2009 Meta-Analysis
Alexiou et al. J Crit Care 2009; 24(4):515-522
12
HOB Elevation
Population
• Patients receiving mechanical ventilation in
medical and respiratory ICUs
Intervention (RCT)
• Patients were randomly assigned the supine
(N= 47) vs semi-recumbent at 45 degrees
(N=39) positions
Drakulovic et al. Lancet 1999; 354:1851-58.
13
HOB Elevation
Outcomes
• Frequency of clinically suspected pneumonia lower in
semi-recumbent vs supine
– 3 /39 [8%] vs 16/47 [34%]; CI 10.0–42.0, p=0·003
• Frequency of microbiologically confirmed pneumonia
lower in semi-recumbent vs supine
– 2/39 [5%] vs 11/47 [23%]; CI 4.2–31.8, p=0.018
• Independent risk factors:
– Supine body position (OR 6.8 [1.7–26.7], p=0.006)
– Enteral nutrition (OR 5.7 [1.5–22.8], p=0.013)
Drakulovic et al. Lancet 1999; 354:1851-58.
14
HOB Elevation
Population
• Patients receiving mechanical ventilation at 4
university ICUs
Intervention (RCT)
• Patients were randomly assigned to usual
care (N= 109) vs semi-recumbent at 45
degrees (N=112) positions
van Nieuwenhoven et al. CCM 2006;34(2)396-402.
15
HOB Elevation
Outcomes
• Target semi-recumbent position of 45 was not
achieved for 85% of the study time
• Frequency of clinically suspected pneumonia:
– 16/112[14.3%] semi-recumbent vs 20/109 [18.3%] supine
• Frequency of microbiologically confirmed pneumonia
– 13/112 [11.6%] semi-recumbent vs 8/109 [7.3%] supine
• Achieved difference in treatment position (28 vs 10
degrees) did not prevent the development of VAP
van Nieuwenhoven et al. CCM 2006;34(2)396-402.
16
Spontaneous Awakening and
Breathing Trials (SAT &SBT)
17
Spontaneous Awakening and Breathing
Trials : VAP Prevention Guidelines
• Does not specifically address SAT and SBT, however
supports weaning.
• CDC; MMWR Recomm Rep. 2004;53:1-36
• Recommends use of daily interruption or lightening of
sedation to avoid constant heavy sedation and to
facilitate and accelerate weaning.
• Does not specifically address SBT.
• ATS/IDSA; AJRCCM 2005;171(4):388-416.
18
Spontaneous Awakening and Breathing
Trials : VAP Prevention Guidelines
• Guideline excluded studies that evaluated SAT and SBT.
• Canadian VAP Prevention Guidelines; J Crit Care
2008;23(1):138-147.
• Recommends the use of combining a daily assessment of
readiness wean and daily sedation interruption.
• SHEA; ICHE 2008;29:S31-S40.
19
Spontaneous Awakening Trials
Population
• Medical ICU patients on mechanical ventilation
Intervention (RCT)
• Control group: no interruption (N= 68)
• Rx group: daily interruption (N= 60) sedation held
daily until the patients were awake and could follow
instructions or uncomfortable or agitated.
• All patients received an infusion of morphine for
analgesia.
Kress et al. NEJM 2000; 342:1471-77
20
Spontaneous Awakening Trials
Outcomes
• 2.4 day reduction duration mechanical ventilation
– 33% relative risk reduction
• 3.5 day reduction ICU length of stay
– 35% relative risk reduction
• Hospital length of stay unchanged: control group 16.9
days (8.5-26.6 days) compared to rx group 13.3 days
(7.3-20.0 days).
Kress et al. NEJM 2000; 342:1471-77
21
Spontaneous Breathing Trials
Population
• Adult medical and coronary ICU patients on
mechanical ventilation (n=300)
Intervention (RCT)
• Control group: daily screening (RSBI*) (n=151)
• Experimental group: daily screening (RSBI) followed
by 2-hour SBT (n=149) if they passed the screening
test
• Physicians were notified when their patients
successfully completed the trial of spontaneous
breathing.
*RSBI: rapid shallow breathing index
Ely et al. NEJM 1996; 335:1864-69.
22
Spontaneous Breathing Trial (SBT)
• Patient passes SBT safety screen
• Ventilatory support is removed and the patient is
allowed to breathe through either a T-tube circuit or a
ventilatory circuit using “flow triggering” (rather than
triggering by pressure) with a continuous positive
airway pressure of 5 cm of water.
• No changes are required in the fraction of inspired
oxygen or the level of positive end-expiratory
pressure.
23
Spontaneous Breathing Trials
Outcomes
• 1.5 day reduction duration mechanical ventilation
– 25% relative risk reduction
• 1.0 day reduction ICU length of stay
– Not statistically significant
• Reductions total ICU costs
• Reductions in complications including reintubation
Ely et al. NEJM 1996; 335:1864-69.
24
Treatment protocol
Girard et al. Lancet 2008; 371: 126–34
25
ABC Trial: Awakening and Breathing
Controlled trial
Population
• 336 ICU patients on mechanical ventilation
• Four tertiary-care hospitals
Intervention (RCT)
• Control group: sedation per usual plus daily SBT
(n=168)
• Rx group: daily SAT followed by SBT (n=168) All
patients received an infusion of morphine for
analgesia.
Girard et al. Lancet 2008; 371: 126–34
26
ABC Trial: Awakening and Breathing
Controlled trial
• 3.1 increased days without mechanical ventilation
– 21% relative risk increase
• 3.8 day reduction ICU length of stay
– 29% relative risk reduction
• 4.3 day reduction hospital length of stay
– 22% relative risk reduction
• Number needed to treat (NNT) = 7.4 for one life
saved
Girard et al. Lancet 2008; 371: 126–34
27
Oral Care with Chlorhexidine
28
Use Chlorhexidine when performing
oral care: VAP Prevention Guidelines
• No specific recommendation can be made for the
routine use of an oral chlorhexidine rinse.
(Unresolved issue)
• CDC; MMWR Recomm Rep. 2004;53:1-36
• Recommends regular oral care. CHG effective in
specific populations (ie: CABG); routine use is not
recommended until more data is available.
• ATS/IDSA; AJRCCM 2005;171(4):388-416.
29
Chlorhexidine when performing oral
care: VAP Prevention Guidelines
• Oral antiseptic CHG should be considered. Based on 1
level 1 and 2 level 2 trials, use of oral antiseptic CHG may
decrease VAP. Safety, feasibility, and cost considerations
are all very favorable.
• Canadian VAP Prevention Guidelines; J Crit Care
2008;23(1):138-147.
• Perform regular oral care with an antiseptic solution. While
the use of CHG is not specifically addressed, the 3 studies
cited by the guideline all focused on cardiovascular surgery
and demonstrated the efficacy of CHG.
• SHEA; ICHE 2008;29:S31-S40.
30
CHG Oral Care: Evidence
• Gingival and dental plaque rapidly becomes
colonized with bacteria in intubated patients
due to poor oral hygiene and lack of
mechanical elimination
• Meticulous oral care reduces microbial
burden in upper airway
• Safety and feasibility of CHG oral care are
favorable
DeRiso A. Chest. 1996;109:1556.
Chan E. BMJ. 2007;10:1136.
Chlebicki M Crit Care Med 2007;35:595.
31
Oral Antiseptics: 2011 Systematic
Review and Meta-Analysis
• 12 RCTs evaluating CHG (2341 patients)
• Overall 38% VAP reduction
– RR 0.72, 95%CI 0.55-0.94
• Results varied by CHG concentration
– 2% > 0.2% > 0.12%
Labeau Lancet Infect Dis 2011;11:845-54
32
Oral Antiseptics: A Systematic
Review and Meta-Analysis
Labeau Lancet Infect Dis 2011;11:845-54
33
Oral Antiseptics: A Systematic
Review and Meta-Analysis
• Variation by ICU Type
• Cardiac Surgery only (n=2, 914 patients)
– RR 0.41, 95% CI 0.17-0.98
• Mixed ICUs (n=10, 1294 patients)
– RR 0.77, 95% CI 0.58-1.02
• Surgery or Trauma (n=2, 273 patients)
– RR 0.67, 95% CI 0.50-0.88
Labeau Lancet Infect Dis 2011;11:845-54
34
CHG Oral Care:
Recommendations
• Chlorhexidine 0.12% oral solution (15 ml bid until
24 hours after extubation) for all intubated
patients
• Contraindications
– Hypersensitivity to component of solution
– <2 months of age
– There is the possibility of direct contact with
meninges
• Brush patients’ teeth bid with soft toothbrush to
remove dental plaque prior to using CHG
• Oral Care should be performed q4;
• Oral Care with CHG should be performed q12.
35
Subglottic suctioning ETTs in
patients mechanically
ventilated for >72 hours
36
Subglottic suctioning ETTs: VAP
Prevention Guidelines
• Recommend ETTs with a dorsal lumen above the
cuff to allow drainage (by continuous or frequent
intermittent suctioning) of tracheal secretions.
• CDC; MMWR Recomm Rep. 2004;53:1-36
• Recommend specially designed endotracheal tube
(dorsal lumen) for continuous aspiration of subglottic
secretions
• ATS/IDSA; AJRCCM 2005;171(4):388-416.
37
Subglottic suctioning ETTs: VAP
Prevention Guidelines
• Recommended subglottic secretion drainage in
patients expected to be mechanically ventilated for
more than 72 hours.
• Canadian VAP Prevention Guidelines; J Crit
Care 2008;23(1):138-147.
• Recommend the use of cuffed ETT with in line or
subglottic suctioning.
• SHEA; ICHE 2008;29:S31-S40.
38
Subglottic suctioning ETTs:
Evidence
• Drainage of subglottic secretions lessens the
risk of aspiration
• Specially designed endotracheal tubes have
been developed to provide continuous or
intermittent subglottic secretion removal
Kollef M. Chest. 1999;116:1339.
Smulders K. Chest 2002;121:858.
39
Subglottic Suctioning ETTs
40
Subglottic Suctioning ETTs:
Evidence
• 13 RCTs evaluating subglottic secretion
drainage (2442 patients)
• Overall 45% VAP reduction
– RR 0.55 (95% CI 0.46–0.66)
– NNT = 11
• 1.5 day ICU LOS reduction
• 1.1 day duration of MV reduction
Muscedere J. Crit Care Med. 2011;39:1985.
41
Subglottic Suctioning ETTs: A
Systematic Review and Meta-Analysis
Muscedere J. Crit Care Med. 2011;39:1985.
42
Subglottic Suctioning ETTs: A
Systematic Review and Meta-Analysis
Similar results if limited to studies of high methodologic quality
Muscedere J. Crit Care Med. 2011;39:1985.
43
Subglottic Suctioning ETTs: A Cost
Effectiveness Analysis
Conclusion:
Regular utilization of CSS-ETs may produce significant cost savings,
irrespective of the increased costs of CSS-ETs.
Shorr et al. Chest 2001;119:228-235
44
Potential Limitations
• Potential limitations of Shorr et al. study
• Limited to patients requiring more than 48
hours of ventilation
• Base case assumed 25% VAP incidence
• Did not include costs of suction canisters
Hallais et al. Infect Control Hosp Epidemiol
2011;32(2):131-135
45
Subglottic Suctioning ETTs: A Cost
Effectiveness Analysis
• Design: Cost-benefit analysis, based on hypothetical
replacement of standard ETT with CSS ETT
• Setting: all 416 patients receiving mechanical
ventilation in tertiary-care SICU in France (2006)
• Methods: base case 7.9 VAP per 100 ventilated
patients; 29% reduction in VAP with CSS; included
sensitivity analysis (lowest VAP rate 6.6%)
• Conclusion: CSS was cost-effective even when
assuming the most pessimistic scenario of VAP
Hallais et al. Infect Control Hosp Epidemiol
incidence and costs.
2011;32(2):131-135
46
Subglottic Suctioning ETTs:
Recommendations
• Continuous subglottic suctioning system
recommended for patients expected to be
mechanically ventilated for >72 hours
• Unanswered questions
– How to identify pts that will require MV > 3
days; most studies used SDD ETTs for all
patients undergoing major surgery
– Should ETTs be changed if patients require MV
> 3 days.
47
Tools and Resources
• Educational Resources
–
–
–
–
Fact sheets
Literature reviews
Powerpoint slides
Audio recordings
• VAP and CUSP toolkits
• Social networking
http://www.hopkinsmedicine.org/quality_safety_research_group/
our_projects/ventilator_associated_pheumonias/
48
Science of Safety
• Safety is a property of systems
• Standardize with protocols, create checklists, learn
when things go wrong
• We need lenses to see the system
• Recognize these principles apply to
technical and team work
• Teams make wise decisions when there is
diverse and independent input
49
Next Steps
• Review evidence with CUSP team
• Think about how best to educate staff
– Use educational tools
– Create ‘resource book’ in ICU
• Make sure staff know who to contact in your
ICU if questions or concerns
• Review unit level policies and protocols and
work toward alignment with recommendations
• Develop and share policies and protocols
50
Questions
– Karol G. Wicker, MHS
Senior Director, Quality Policy & Advocacy
Maryland Hospital Association
kwicker@mhaonline.org
– Mary Catanzaro RN BSMT CIC
Project Manager HAIs
Hospital and Healthsystem Association of Pennsylvania
mcatanzaro@haponline.org
51
References
Slide 9, 18, 29, 37
• CDC; MMWR Recomm Rep. 2004;53:1-36
• ATS/IDSA; AJRCCM 2005;171(4):388-416.
Slide 10, 19, 30, 38
• Canadian VAP Prevention Guidelines; J Crit Care 2008;23(1):138-147.
• SHEA; ICHE 2008;29:S31-S40.
Slide 11, 12
• Alexiou VC, Vrettos Ierodiakonou V, Dimopoulos G, Falagas ME, Impact of
patient position on the incidence of ventilator-associated pneumonia: A metaanalysis of randomized controlled trials J Crit Care 2009; 24(4):515-522
52
References
Slide 13, 14
• Drakulovic MB, Torres A, Bauer TT, Nicolas JM, Nogué S, Ferrer M. Supine
body position as a risk factor for nosocomial pneumonia in mechanically
ventilated patients: a randomised trial. 1999; 354:1851-58.
Slide 15, 16
• Nieuwenhoven CA, Vandenbroucke-Grauls C, van Tiel Frank FH, Joore HCA,
Schijndel, RJ, Strack MD, Van der Tweel I, Graham R, Bonten MJ Feasibility
and effects of the semirecumbent position to prevent ventilator-associated
pneumonia: A randomized study. CCM 2006;34(2)396-402.
Slide 20, 21
• Kress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative
infusions in critically ill patients undergoing mechanical ventilation. NEJM 2000;
342:1471-77
53
References
Slide 22, 24
• Ely EW, Baker AM, Dunagan DP, Burke HL, Smith AC, Kelly PT, Johnson MM,
Browder RW, Bowton DL,Haponik EF. Effect on the duration of mechanical
ventilation of identifying patients capable of breathing spontaneously. NEJM
1996; 335:1864-69.
Slide 25, 26, 27
• Girard TD, Kress JP, Fuchs BD, Thomason JW, Schweickert WD, Pun
BT, Taichman DB, Dunn JG, Pohlman AS, Kinniry PA, Jackson JC, Canonico
AE, Light RW, Shintani AK, Thompson JL, Gordon SM, Hall JB, Dittus
RS, Bernard GR, Ely EW. Efficacy and safety of a paired sedation and ventilator
weaning protocol for mechanically ventilated patients in intensive care
(Awakening and Breathing Controlled trial): a randomized controlled trial. Lancet
2008; 371: 126–34
54
References
Slide 31
• DeRiso AJ, Ladowski JS, Dillon TA, Justice JW, Peterson AC. Chlorhexidine
gluconate 0.12% oral rinse reduces the incidence of total nosocomial respiratory
infection and nonprophylactic systemic antibiotic use in patients undergoing
heart surgery. Chest. 1996; 109: 1556-1561.
• Chan EY, Ruest A, Meade MO, Cook DJ. Oral decontamination for prevention of
pneumonia in mechanically ventilated adults: systematic review and metaanalysis. BMJ. 2007;10:1136
• Chlebicki MP, Safdar N, Topical chlorhexidine for prevention of ventilatorassociated pneumonia: a meta-analysis. Crit Care Med 2007;35:595.
Slide 32, 33, 34
• Labeau SO, Van de Vyver K, Brusselaers N, Vogelaers D, Blot SI. Prevention of
ventilator-associated pneumonia with oral antiseptics: a systematic review and
meta-analysis. Lancet Infect Dis 2011;11:845-54
55
References
Slide 39
• Kollef MH, Skubas NJ, Sundt TM. A randomized clinical trial of continuous
aspiration of subglottic secretions in cardiac surgery patients. Chest. 1999
Nov;116(5):1339-46.
• Smulders K, van der Hoeven H, Weers-Pothoff I, Vandenbroucke-Grauls C. A
randomized clinical trial of intermittent subglottic secretion drainage in patients
receiving mechanical ventilation. Chest. 2002 Mar;121(3):858-62.
Slide 40
• Vallés J, Artigas A, Rello J, Bonsoms N, Fontanals D, Blanch L, Fernández R,
Baigorri F, Mestre J. Continuous aspiration of subglottic secretions in preventing
ventilator-associated pneumonia. Ann Intern Med. 1995 Feb 1;122(3):179-86.
56
References
Slide 41, 42, 43
• Muscedere J, Rewa O, McKechnie K, Jiang X, Laporta D, Heyland DK.
Subglottic secretion drainage for the prevention of ventilator-associated
pneumonia: a systematic review and meta-analysis. Crit Care Med. 2011
Aug;39(8):1985-91.
Slide 44
• Shorr AF, O'Malley PG. Continuous subglottic suctioning for the prevention of
ventilator-associated pneumonia : potential economic implications. Chest. 2001
Jan;119(1):228-35.
Slide 45, 46
• Hallais C, Merle V, Guitard PG,Moreau A, Josset V, Thillard D, Haghighat S,
Veber B, Czernichow P. Is continuous subglottic suctioning cost-effective for the
prevention of ventilator-associated pneumonia? Infect Control Hosp Epidemiol.
2011 Feb;32(2):131-5.
57