CUSP for VAP: EVAP On Boarding Call #5: Evidence Review Sean Berenholtz M.D., MHS Nishi Rawat, M.D....

CUSP for VAP: EVAPOn 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

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On Boarding Call Schedule –Tuesdays 8/21–9/25 @ 2:00

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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

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

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Process measures: Daily evaluation

1. Head of Bed Elevation (HOB)a. Use of a semi-recumbent position ( ≥ 30 degrees).

2. Spontaneous Awakening and Breathing Trials (SAT & SBT)a. Make a daily assessment of readiness to wean with the use of the SAT and SBT.

3. Oral Carea. At least 6 times per day

4. Oral Care with Chlorhexidinea. Should be included in the oral care regimen 2 times per day

5. Subglottic Suctioning a. Use subglottic suctioning ETTs in patients expected to be mechanically

ventilated for >72 hours 5

Policy Based Structural Measures :

1. Use a closed ETT suctioning system

2. Change close suctioning catheters only as needed

3. Change ventilator circuits only if damaged or soiled

4. Change HME every 5-7 days and as clinically indicated

5. 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 protocolETT endotrachael tube; HME heat moist exchanger; NIVV non-invasive ventilation

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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

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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 semi-

recumbent position (30-45 degrees) rather than supine to prevent aspiration.

• ATS/IDSA; AJRCCM 2005;171(4):388-416.

• 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.

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Head of Bed Elevation : VAP Prevention Guidelines

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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

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HOB Elevation: 2009 Meta-Analysis

Alexiou et al. J Crit Care 2009; 24(4):515-522

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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.

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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.

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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.

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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.

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Spontaneous Awakening and Breathing Trials (SAT &SBT)

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.

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• 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.

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Spontaneous Awakening and Breathing Trials : VAP Prevention Guidelines

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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

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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

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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 indexEly et al. NEJM 1996; 335:1864-69.

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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.

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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.

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Treatment protocol

Girard et al. Lancet 2008; 371: 126–34

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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

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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

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Oral Care with Chlorhexidine

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.

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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.

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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.

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

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Oral Antiseptics: A Systematic Review and Meta-Analysis

Labeau Lancet Infect Dis 2011;11:845-5433

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

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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.

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Subglottic suctioning ETTs in patients mechanically ventilated for >72 hours

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.

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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.

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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.

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Subglottic Suctioning ETTs

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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.

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.

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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

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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

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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 incidence and costs. Hallais et al. Infect Control Hosp Epidemiol

2011;32(2):131-135

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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.

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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/

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

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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

Questions

– Karol G. Wicker, MHSSenior 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

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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 meta-analysis of randomized controlled trials J Crit Care 2009; 24(4):515-522

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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

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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

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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 meta-analysis. BMJ. 2007;10:1136

• Chlebicki MP, Safdar N, Topical chlorhexidine for prevention of ventilator-associated 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

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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• Zolfaghari PS, Wyncoll, DLA. The tracheal tube: gateway to ventilator-

associated pneumonia. Critical Care. 2011; 15:310.

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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.