1. © The Johns Hopkins University and The Johns Hopkins Health System Corporation, 2011 VAP Prevention Bundle: Evidence Review for Oral Care and Subglottic Suction ETTs Armstrong Institute for Patient Safety and Quality

2. Objectives To review the development of a VAP Prevention Bundle To review the evidence to support interventions in the VAP Prevention Bundle

3. Development of ‘VAP Prevention Bundle’ Funded by NIH/NHLBI –“A Multifaceted Intervention to Reduce Ventilator- Associated Pneumonia in the ICU” –Delphi process led by RAND researcher –Implement in statewide cohort of ICUs AHRQ funding –“ Comprehensive Unit-based Safety Program (CUSP) for Ventilator-Associated Pneumonia” –Pilot test in at least 2 hospitals in 2 states in anticipation of a national QI VAP Prevention project Armstrong Institute for Patient Safety and Quality 3

4. VAP Prevention Guidelines CDC Guidelines MMWR Recomm Rep. 2004;53:1-36 American Thoracic Society/ Infectious Diseases Society of America AJRCCM 2005;171(4):388-416. Canadian VAP Prevention Guidelines J Crit Care 2008;23(1):138-147. Society for Healthcare Epid of America ICHE 2008;29:S31-S40. Armstrong Institute for Patient Safety and Quality 4

5. Development of a New VAP Prevention Bundle: Delphi Process Interdisciplinary committee (n=155) –Focus on 65 guideline interventions Two web based rating cycles –First cycle, focus on importance effectiveness, strength and volume of clinical evidence, consistency of findings, and relevance –Second cycle, focus on importance, measurability and implementation feasibility Scale of 1 to 9, where 1 = low, 9 = essential > 90% response rates Armstrong Institute for Patient Safety and Quality 5

6. Process measures: Daily evaluation Use a semi-recumbent position ( ≥ 30 degrees). Make a daily assessment of readiness to wean. Use sedation protocol with sedation vacation and validated sedation scale (i.e. RASS) at least daily. Use chlorhexidine when performing oral care. Use subglottic suctioning ETTs in patients expected to be mechanically ventilated for >72 hours Armstrong Institute for Patient Safety and Quality 6

7. Structural measures: Quarterly evaluation 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 Armstrong Institute for Patient Safety and Quality 7 ETT endotrachael tube; HME heat moist exchanger; NIVV non-invasive ventilation

8. Structural measures: Quarterly evaluation 7.Use early mobility protocol 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 Armstrong Institute for Patient Safety and Quality 8

9. Chlorhexidine when performing oral care

10. Chlorhexidine when performing oral care: VAP Prevention Guidelines No 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. Armstrong Institute for Patient Safety and Quality 10

11. 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. Armstrong Institute for Patient Safety and Quality 11

12. 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.

13. Topical CHG: 2007 Systematic Review and Meta-Analysis 7 RCTs evaluating CHG (1650 patients) Overall 26-30% VAP reduction –Fixed effects RR 0.74, 95%CI 0.56-0.96 –Random effects RR 0.70, 95%CI 0.47-1.04 Cardiac Surgery subgroup –59% VAP reduction –RR 0.41, 95% CI 0.17-0.98 Armstrong Institute for Patient Safety and Quality 13 Chlebicki MP. Crit Care Med 2007;35:595-602

14. Topical CHG: 2007 Systematic Review and Meta-Analysis Armstrong Institute for Patient Safety and Quality 14 Chlebicki MP. Crit Care Med 2007;35:595-602

15. 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% Cardiac Surgery ICUs 59% VAP reduction –RR 0.41, 95% CI 0.17-0.98 Armstrong Institute for Patient Safety and Quality 15 Labeau Lancet Infect Dis 2011;11:845-54

16. Oral Antiseptics: A Systematic Review and Meta-Analysis Armstrong Institute for Patient Safety and Quality 16 Labeau Lancet Infect Dis 2011;11:845-54

17. 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 Armstrong Institute for Patient Safety and Quality 17 Labeau Lancet Infect Dis 2011;11:845-54

18. CHG Oral Care: Recommendations Chorhexidine 0.12% oral solution (15 ml bid until 24 hours after extubation) for all intubated patients Exceptions Hypersensitivity to component of solution <18 years of age Brush patients’ teeth bid with soft toothbrush to remove dental plaque prior to using CHG Continue routine q4 hr routine oral care: cleaning and moistening mouth using oral swabs or sterile water and gauze

19. Subglottic suctioning ETTs in patients mechanically ventilated for >72 hours

20. 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. Armstrong Institute for Patient Safety and Quality 20

21. 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. Armstrong Institute for Patient Safety and Quality 21

22. 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.

23. Valles J, et al. Ann Intern Med. 1995;122:179. Subglottic Suctioning ETTs

24. 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.

25. Subglottic Suctioning ETTs: A Systematic Review and Meta-Analysis Armstrong Institute for Patient Safety and Quality 25 Muscedere J. Crit Care Med. 2011;39:1985.

26. Subglottic Suctioning ETTs: A Systematic Review and Meta-Analysis Armstrong Institute for Patient Safety and Quality 26 Muscedere J. Crit Care Med. 2011;39:1985. Similar results if limited to studies of high methodologic quality Two studies evaluated only cardiac surgery patients (n=1057)

27. Subglottic Suctioning ETTs: A Cost Effectiveness Analysis Armstrong Institute for Patient Safety and Quality 27 Conclusion: Regular utilization of CSS-ETs may produce significant cost savings, irrespective of the increased costs of CSS-ETs.

28. 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.

29. Next Steps Discussion and agreement? Data Collection –Process measures –Opportunity to advance the science Timeline Armstrong Institute for Patient Safety and Quality 29