1. Monitoring Patients on Mechanical Ventilation: A New Paradigm Terri Conner, Ph.D. Nybeck Analytics May 2012

2. A Review of Select Literature Gerard et al. Efficacy and safety of a paired sedation and ventilator weaning protocol for mechanically ventilated patients in intensive care (Awakening and Breathing Controlled Trial): a randomised controlled trial. Lancet 2008;371:126 Klompas et al. Multicenter evaluation of a novel surveillance paradigm for complications of mechanical ventilation. Plos One 2011;6:e18062 Klompas et al. Rapid and reproducible surveillance for ventilator-associated pneumonia. Clin Infect Dis 2012;54:370

3. Girard et al. Efficacy and Safety of Paired Sedation and Ventilator Weaning Protocol Purpose: Assess protocol that pairs SAT and SBT Vanderbilt Univ of Medicine Coordinating Center supervised 4 large medical centers – St Thomas Hospital (Nashville) – Univ of Chicago Hospitals (Chicago) – Hospital of Univ Penn (Philadelphia) – Penn Presbyterian Med Ctr (Philadelphia) 336 mechanically ventilated pts randomly assigned to receive daily SAT/SBT or sedation per usual care plus daily SBT SAT: spontaneous awakening trial; SBT: spontaneous breathing trial

4. Methods

5. 1:Number of ventilator free days 2: – time to discharge from ICU, from hospital; – all-cause 28 day mortality; – 1 yr survival; – duration of coma/delirium Endpoints

6. Results

9. Klompas et al. Multicenter Evaluation of a Novel Surveillance Paradigm Purpose: To compare outcomes for VAC and CAP – Time for surveillance – Duration of mechanical ventilation – LOS in ICU and hospital – Mortality

10. Methods Three academic medical centers – Brigham and Women’s (Boston) – Ohio State Univ Med Ctr (Columbus) – LDS Hospital (Salt Lake City) Retrospective review: Each hospital randomly selected 100 pts vented for 2-7 days and 100 pts vented >7 days – Each patient was assessed for VAC and for VAP

11. Definitions VAC – PEEP and FiO2 per day recorded – VAC defined as an increase in a patient’s daily minimum PEEP by 2.5 cm H2O sustained for >=2 days or an increase in the daily minimum FiO2 by >=15 points sustained for >=2 days after a minimum of 2 days of stable or decreasing daily minimum PEEPs and FiO2s respectively VAP – NHSN definition, determined by 1-3 IPs

12. A total of 597 patients with 6,347 vent days – Of these 9% met VAP definition (8.8 per 1000 vent days) and 23% met VAC definition (21.2 per 1000 vent days) – Among the two hospitals that recorded review time VAP reviewer required 260 hours to assess 400 patients (mean 39 mins per patient) VAC reviewer required 12 hours to assess 400 patients (1.8 mins per patient) Results

13. Comparison of Outcomes

14. Matched Patient Outcomes

15. Sensitivity and Specificity of VAC relative to VAP Sensitivity 56% (95% CI 43-69%) Specificity 95% (95% CI 92-97%) Patients who met criteria for both VAC and VAP had the longest LOS, those who met criteria for only 1 of 2 had similar intermediate LOS, and those who were negative for both had the shortest LOS.

16. Comment Many observers have questioned the validity of comparing VAP rates between hospitals as well as the clinical significance of reports of ‘zero’ rates – In this study, among patients ventilated for 7 days or less, the observed VAP rates varied from 0 to 4% but VAC rates varied only 7 to 9%, suggesting a measure that is both more uniform and able to detect complications in populations with ostensibly zero VAPs

17. Klompas et al. Rapid and Reproducible Surveillance for VAP

18. Data Collection

19. Results Review with conventional definition took 39 mins per patient while, with streamlined definition, review took 3.5 minutes per patient Both definitions predicted significant increases in duration of mechanical ventilation and ICU LOS Neither definition was associated with increased hospital mortality

20. Comment Radiographs add little accuracy to the diagnosis of VAP or prediction of patient outcomes

21. Issues Change in surveillance methodology – We need better measurement metrics that better correlate with patients’ outcomes Improvement with new rates – We need to focus on strategies to improve care for ventilated patients

22. “Wake Up and Breathe” Quality Improvement Collaborative Leadership from CDC and IHI working with Epicenters and multiple large medical centers across the country – Epicenters are at Harvard (Boston), Duke Univ (Durham), Washington Univ (St Louis), Univ Chicago (Chicago), Univ Penn (Philadelphia), Vanderbilt (Nashville) – Their initiative launched April 24, 2012 We have a unique opportunity to act as a ‘second cohort’ in this initiative to engage front line clinicians, healthcare specialists, and hospital leadership on implementing opt-out protocols

23. Wake Up and Breathe The initiative team is – Working to incorporate SAT and SBT documentation into existing workflows – Working with new definitions for ventilator-associated events, slated for NHSN implementation in 2013 The new definition focuses on complications of mechanical ventilation – It is important to monitor and prevent ALL complications in ventilated patients – Respiratory deterioration after a period of improvement or stability can be objectively defined using ventilator settings

24. Our Goal Implement the new definitions to monitor the success of the paired SAT/SBT initiative – Address and adopt the new requirements for surveillance – Demonstrate improvement in patient care

25. Implications Hospitals will have to continue with current VAP reporting on NHSN, but collect minimal data for PfP reporting until NHSN definitions officially change – Benefits your team as early adopters to be prepared with changes occur – Strengthens data contributing to value of changes – Consistent data over the PfP time period

26. Tasks (under development) Implement Epicenters’ Wake Up and Breathe protocol for paired SAT/SBT – Copy of protocol on the CoP and TCQPS websites – Training will be provided in late May/June by our Harvard colleagues

27. Tasks (under development) Complete baseline report Complete minimal data elements – Might be able to retrieve some data electronically

28. Review and Next Steps Adoption of the Wake Up and Breathe initiative is voluntary – We are looking for early adopters! Continuing with NHSN current definitions will present a problem in 2013 – Consider this dilemma in context of PfP Discuss this initiative with your team and hospital leadership as soon as possible – Contact Terri Conner no later than May 25, 2012 with your team’s decision

29. Categories of Decision We are going to continue on as planned and will move to new NHSN definitions when required We are going to begin gathering new data metrics in anticipation of NHSN changes, but are not implementing the SAT/SBT protocol We are going to begin gathering new data metrics and will plan to implement the SAT/SBT protocol no later than 2013

30. VAP Project Manager Terri Conner, Ph.D. Terri@Nybeck.Net (512) 796-1099