The CDC Prevention Epicenters’ Wake Up and Breathe Collaborative CUSP for Mechanically Ventilated Patients August 4, 2015 Michael Klompas MD, MPH, FIDSA, FSHEA Harvard Medical School, Harvard Pilgrim Health Care Institute, and Brigham and Women’s Hospital, Boston, USA

Disclosures Grant funding from CDC Honoraria from the Hospital Association of New York State

Critical Care Medicine 2013;41:2467-2475 The group came up with VAE definitions. Critical Care Medicine 2013;41:2467-2475

Ventilator-Associated Events (VAE) Sustained rise in daily minimum PEEP ≥3cm or FiO2 ≥20 points after a period of stable or improving daily minimum PEEP or FiO2 Date PEEP (min) FiO2 (min) Jan 1 10 100 Jan 2 5 50 Jan 3 40 Jan 4 Jan 5 8 60 Jan 6 Jan 7 Jan 8 Jan 9 VAE The core condition for VAE surveillance is a VAC, or ventilator-associated condition. Conceptually, it’s simply a patient who was stable or improving on a vent and then suffered a period of sustained deterioration. This is measured by looking at the vent settings. We look for increases in daily minimum PEEP and FiO2. We use the daily minimum in order to capture the patient’s best value of the day.

Canadian Critical Care Trials Group ABATE Study 11 ICUs, 1330 patients, VAE vs VAP Surveillance 9.9 events per 1000 vent days VAP 10.6 events per 1000 vent days VS 100 39 109 What do we know then about VAEs? Well there are now almost a dozen studies of VAE epidemiology. This one is from the Canadian Critical Care Trials Group. They compared VAE vs VAP surveillance in 11 ICUs, more than 1300 patients. They found that VAE and VAP rates were very similar but they captured very different populations of patients. There was very little overlap between the two groups. It’s worth thinking for a moment about the 109 patients that were VAP positive but VAE negative. By definition, these were VAPs that did not require a sustained increase in ventilator support (if they had, they would have been VAEs). One wonders about the clinical significance of these physiologically more benign events. Muscedere et al. Chest 2013;144:1453

Qualitative analysis of 153 VAEs Royal Brisbane & Women’s Hospital, Queensland, Australia Abx + Furosemide 6% Pneumonia 38% Edema 26% There are also now at least 5 studies assessing the clinical correlates of VAE. What sorts of clinical events tend to trigger VAEs? The results are consistent across all 5 studies. Almost all VAEs are triggered by 1 of 4 conditions: pneumonia, volume overload, atelectasis, or ARDS. Atelectasis 15% Other 8% ARDS 6% Hayashi et al. Clin Infect Dis 2013;56:471-477

VAE = VAP + CHF + ARDS + Atelectasis Rather, VAEs are a mix of pneumonias, volume, ARDS, and atelectasis.

Attributable Mortality of VAE versus VAP USA – 3 centers PLoS ONE 2011;6:e18062 USA – 8 centers Crit Care Med 2012;40:3154 Canada – 11 centers Chest 2013;144:1453 Netherlands – 2 centers Am J Resp Crit Care Med 2014;189:947 USA – 2 centers Crit Care Med 2014;ePub USA – 1 center Infect Control Hosp Epidemiol 2014;5:502 What is clear, though, is that VAEs are bad for patients. Here are findings from 6 studies estimating the attributable mortality of VAEs. The results are very consistent. VAEs appear to double the risk of dying compared to similar patients without VAEs. Four of the six studies also estimated the attributable mortality of VAP and we can see that in 3 out of 4 studies, the attributable mortality for VAE was higher. 0.5 1 2 5 10 Odds Ratio or Hazard Ratio 8

Fewer VAEs How do we get there? http://www.macrobert.org/assets/images/Film/May%202013/WizardOfOz_214Pyxurz.jpg How do we get there?

Minimize duration of mechanical ventilation

The CDC Prevention Epicenters’ Wake Up and Breathe Collaborative Every Patient  Every Day

www.keepcalm-o-matic.co.uk/p/keep-calm-use-sedatives/

The downsides of sedation Suppresses respiratory drive Prolongs ventilator dependence Increases risk for delirium Impairs mobility Increases risk for pneumonia, atelectasis, ARDS, deconditioning, etc.

140 patients randomized to routine sedation versus no sedation Lancet 2010;375:475-80 140 patients randomized to routine sedation versus no sedation 70 prescribed routine sedation (propofol then midazolam) 70 prescribed no sedation (morphine boluses PRN) Patients with no sedation Mean 4.2 (95% CI 0.3-8.1) fewer days on the vent Shorter ICU stay (HR 1.86, 95% CI 1.1-3.2) Shorter hospital stay (HR 3.6, 95% CI 1.5-9.1) More agitated delirium (20% versus 7%) but no difference in self-extubations 1:1 nursing

Spontaneous Awakening Trials (SATs) Putting Our Patients to the Test Spontaneous Awakening Trials (SATs) We want to give our patient’s the minimum amount of sedation necessary for comfort How do we know if we’ve reached the minimum or not? Give them a challenge: stop all sedatives & observe Spontaneous Breathing Trials (SBTs) We want to extubate our patients as soon as it is safe to do so How do we know if we’ve reached that point or not? Give them a challenge: turn down the vent or give them a T-piece & observe

N=128 NEJM 2000;342:1471-7 Crit Care Med 2004;32:1272

Lancet 2008;371:126-34

Restart sedatives at ½ prior dose No oscillator No active seizures No benzos for ETOH No agitation No paralytics No active MI Normal intracranial pressure No planned surgery in 24hr SAT Safety Screen pass Anxiety, agitation, or pain Respiratory rate >35/min SpO2 <88% Respiratory distress Acute cardiac dysrhythmia Diaphoresis Heart rates >130 Fail SAT Perform SAT pass Screen for SBT Restart sedatives at ½ prior dose

Perform SBT Extubate pass pass SBT Safety Screen Fail SBT Resume Inspiratory efforts Oxygen saturation 88% FiO2 50% PEEP 8-10cm H2O No active MI No paralytics No agitation (RASS  +2) Low or no vasopressors SBT Safety Screen pass Agitation or diaphoresis Respiratory rate >35/min Respiratory rate <8/min SpO2 <88% Mental status change Acute cardiac dysrhythmia Fail SBT Perform SBT pass Resume Vent Support Extubate

CDC Prevention Epicenters’ Wake Up and Breathe Collaborative Goal: prevent VAEs through less sedation and earlier liberation from mechanical ventilation Mechanism: paired daily spontaneous awakening trials and breathing trials (SATs and SBTs) Am J Resp Crit Care Med 2015;191:292-301

CDC Prevention Epicenters’ Wake Up and Breathe Collaborative Opt-out protocol for paired daily SATs and SBTs RNs and RTs initiate SATs/SBTs rather than MDs Automatic for all patients unless MD actively “opts out” Protocol developed by national experts Narrow set of well-defined contraindications Multicenter learning collaborative to aid implementation Am J Resp Crit Care Med 2015;191:292-301

Participants 12 ICUs from 7 hospitals Stroger Cook County Hospital Missouri Baptist Medical Center Duke University Durham VA Durham Regional Hospital North Shore Union Hospital North Shore Salem Hospital Am J Resp Crit Care Med 2015;191:292-301

Collaborative Components All Teach – All Learn Model Each unit designated RN, RT, and MD champions Improvement Advisor to co-ordinate and motivate the collaborative Ronda Sinkowitz-Cochran Two in-person meetings at CDC for all champions Kick-off meeting to orient, educate, and motivate Interim meeting to consolidate and re-motivate Monthly written reports from all ICUs Progress, challenges, successes, and failures Goals for the forthcoming month Monthly collaborative phone calls for all champions Monthly feedback of local and comparative SAT/SBT rates + outcomes Expert advice from CDC and Institute for Healthcare Improvement Consulting faculty: Wes Ely, Terry Clemmer, John Jernigan, Shelley Magill, Michele Balas, Tim Girard, Don Goldmann

Sample extract from a monthly report

Sample unit-specific monthly summary report

Results

Enrollment 3,425 episodes of mechanical ventilation 22,991 days of mechanical ventilation Ventilator-associated events Events per 100 Episodes per 1000 Vent-Days VAC 293 8.5 12.7 IVAC 100 2.9 4.3 Possible Pneumonia 33 1.0 1.4 Probable Pneumonia 17 0.5 0.7 Possible or Probable Pneumonia 50 1.5 2.2 Am J Resp Crit Care Med 2015;191:292-301

Population Summary Episodes 3,425 Vent Days 22,991 Age (mean) 62.8 Male 57% SOFA (mean) 9.3 Mean Vent Days 6.7 days Mean ICU LOS 11.2 days Mean Hospital LOS 21.7 days Hospital Mortality 28% Am J Resp Crit Care Med 2015;191:292-301

Reasons for Intubation Am J Resp Crit Care Med 2015;191:292-301

Unadjusted Outcomes Am J Resp Crit Care Med 2015;191:292-301

SATs and SBTs SBTs: 40% increase SATs: 100% increase Am J Resp Crit Care Med 2015;191:292-301

SBTs Done with Sedatives Off Am J Resp Crit Care Med 2015;191:292-301

Ventilator-Associated Events CDC Prevention Epicenters Wake Up and Breathe Collaborative VAEs: 37% decrease IVAC: 65% decrease Am J Resp Crit Care Med 2015;191:292-301

Ventilator Days and ICU Days ICU: 3 day decrease Ventilator: 2.4 day decrease Am J Resp Crit Care Med 2015;191:292-301

Some Lessons Learned

Get the right people on the bus Night Staff Get the right people on the bus Chief Quality Officer Frontline Nurses Chief Nursing Officer MD Champion ICU Nursing Director RT Champion No VAEs Frontline RTs Chief Medical Officer ICU Medical Director RN Champion Night Staff Head of Respiratory Therapy Day Staff Local Opinion Leaders Frontline Doctors Pharmacists Unit Clerk Image from http://www.kerrvilleisd.net/files/bus_cartoon_tilt.gif

Educate, educate, & re-educate Never assume that everyone– KNOWS about the protocol UNDERSTANDS the protocol AGREES with the protocol Use both formal and informal teaching methods In-services Postings Articles Lectures Morning rounds Hallway discussions

Distinguish between means vs ends SATs are a means, not an end Merely doing SATs alone is insufficient  they’re a means to reduce sedative exposures If staff don’t buy into the idea of managing patients with less sedation, SATs can backfire

“Conclusion: For mechanically ventilated adults managed with protocolized sedation, the addition of daily sedation interruption did not reduce the duration of mechanical ventilation or ICU stay.” SLEAP Study, JAMA 2012;308:1985-92

Midazolam Equivalents JAMA 2012;308:1985-92

Boluses Per Day in the SLEAP Study JAMA 2012;308:1985-92

It’s a marathon not a sprint Image from http://media.mediapost.com/images/inline_image/2012/01/27/Boston-Marathon-B.jpg

SAT Performance, ICU X, June 2012 – March 2013 BTRLW

Choose the right denominator The traditional metric for VAP is events per 1000 vent days What if your intervention, however, is specifically designed to reduce vent days?

CDC Prevention Epicenters Wake Up and Breathe Collaborative VAEs per 100 episodes CDC Prevention Epicenters Wake Up and Breathe Collaborative 37% Decrease Am J Resp Crit Care Med 2015;191:292-301

VAEs per 1000 ventilator-days CDC Prevention Epicenters Wake Up and Breathe Collaborative No Change! Am J Resp Crit Care Med 2015;191:292-301

Summary Hypothesis: earlier liberation from mechanical ventilation will decrease VAE rates Strategy: minimizing sedation, paired daily SATs and SBTs Results Large increase in SAT rates, marginal increase in SBT rates, large increase in SBTs done with sedatives off 37% decrease in VAEs, 65% decrease in IVACs, non-significant decrease in pneumonias 2.4 day decrease in mean vent days, 3.0 day decrease in ICU days, 6.3 day decrease in hospital days Lessons: Get everyone involved Educate, educate, and re-educate Prepare for the long-run Choose the denominator that fits the intervention

Thank You! Michael Klompas (mklompas@partners.org) All RN, RT, and MD Champions and Frontline Providers Dev Anderson Barry Kitch Ellen Arrington Ken Kleinman Hilary Babcock Julie Lankiewicz Michele Balas Ebb Lautenbach Rosie Banks Lingling Li Christina Bruce Shelley Magill Terry Clemmer Kelly McCutcheon-Adams Chris Cox Michael Murphy Wes Ely Carrie O’Neil Vicky Fraser Rich Platt Scott Fridkin Dan Sexton Tim Girard Ronda Sinkowitz-Cochran Don Goldmann Manju Srinivasan Kareema Hunter William Trick John Jernigan Bob Weinstein Meeta Kerlin-Prasad Tiffanee Woodard Michael Klompas (mklompas@partners.org)