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CUSP for VAP: EVAP On Boarding Call #5: Evidence Review. Sean Berenholtz M.D., MHS Nishi Rawat , M.D. September 18 th , 2012 2:00 pm EST/ 11:00 am PST . On Boarding Call Schedule – Tuesdays 8/21–9/25 @ 2:00. Presentation Objectives.
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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
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
Process measures: Daily evaluation • Head of Bed Elevation (HOB) • Use of a semi-recumbent position ( ≥ 30 degrees). • Spontaneous Awakening and Breathing Trials (SAT & SBT) • Make a daily assessment of readiness to wean with the use of the SAT and SBT. • Oral Care • At least 6 times per day • Oral Care with Chlorhexidine • Should be included in the oral care regimen 2 times per day • Subglottic Suctioning • Use subglottic suctioning ETTs in patients expected to be mechanically ventilated for >72 hours
Policy Based Structural Measures : • 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 • Periodically remove condensate from circuits, keeping the circuit closed during the removal, taking precautions not to allow condensate to drain toward patient • Use early mobility protocol ETT endotrachael tube; HME heat moist exchanger; NIVV non-invasive ventilation
Policy Based Structural Measures : • Perform hand hygiene • Avoid supine position • Use standard precautions while suctioning respiratory tract secretions • Use orotracheal intubation instead of nasotracheal • Avoid use of prophylactic systemic antimicrobials • Avoid non-essential tracheal suctioning • Avoid gastric over-distention ETT endotrachael tube; HME heat moist exchanger; NIVV non-invasive ventilation
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.
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.
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
HOB Elevation: 2009 Meta-Analysis Alexiou et al. J Crit Care 2009; 24(4):515-522
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.
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%] vs11/47 [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.
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.
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 vs8/109 [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.
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.
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.
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
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 rxgroup 13.3 days (7.3-20.0 days). Kress et al. NEJM 2000; 342:1471-77
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.
Spontaneous Breathing Trial (SBT) • Patient passes SBT safety screen • Ventilatorysupport 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.
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.
Treatment protocol Girard et al. Lancet 2008; 371: 126–34
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
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
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.
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.
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
Oral Antiseptics: A Systematic Review and Meta-Analysis Labeau Lancet Infect Dis 2011;11:845-54
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
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.
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.
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.
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.
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.
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.
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
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 HospEpidemiol 2011;32(2):131-135
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 HospEpidemiol 2011;32(2):131-135
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.
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
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