Clinical trial NCT01583413: CDC Prevention Epicenters Wake Up and Breathe Collaborative
Official title: CDC Prevention Epicenters Wake Up and Breathe Collaborative
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator-associated Pneumonia
Keywords: Ventilator-associated pneumonia
Lead sponsor: Harvard Pilgrim Health Care
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: Washington University School of Medicine
name: Rush University Medical Center
name: University of Pennsylvania
name: Duke University
name: North Shore Medical Center
First posted: 2012-04-24
Enrollment: 3342
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Ventilator-associated pneumonia (VAP) is a common complication of mechanical ventilation associated with significant morbidity, including prolongation of mechanical ventilation and increased ICU and hospital length-of-stay. Numerous strategies have been proposed to decrease the occurrence of VAP among ventilated patients. Most notably, optimizing the use of daily sedative interruptions and daily spontaneous breathing trials can improve sedative management, decrease ventilator time, improve outcomes for mechanically ventilated patients,and possibly decrease VAP.Combining daily sedative interruption with daily spontaneous breathing trials confers additive improvement in ventilator days, intensive care days, and possibly mortality compared to daily spontaneous breathing trials alone.

The primary aim of this study is to determine the impact of an opt-out protocol for paired daily sedative interruptions and spontaneous breathing trials on VAP rates using a new streamlined VAP definition. The investigators will evaluate the responsiveness of CDC's proposed new surveillance definitions for ventilator-associated events to this quality improvement initiative. The study will be nested within the Epicenters Streamlined versus Conventional VAP Surveillance Study. Nine of the 18 hospitals in the larger study will be participating in this intervention arm.


Eligibility criteria: Inclusion Criteria:

* all patients in participating units on mechanical ventilation for at least one calendar day beting treated with continuous sedatives or standing orders for sedatives. Patients receiving mechanical ventilation through either an endotracheal or tracheostomy tube will be eligible.

Exclusion Criteria:

* moribund status or plans for withdrawal of life support

Primary outcomes:
measure: Change in VAC rate.
timeFrame: 12 months
Secondary outcomes:
measure: ICU-specific outcomes
timeFrame: 12-months
measure: Hospital-specific outcomes
timeFrame: 12-months
measure: Patient-specific outcomes
timeFrame: 12-months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Chicago Prevention Epicenter
state: Illinois
city: Salem
country: United States
facility: North Shore Medical Center
state: Massachusetts
city: St. Louis
country: United States
facility: Washington University Prevention Epicenter
state: Missouri
city: Durham
country: United States
facility: Duke University Prevention Epicenter
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania Prevention Epicenter
state: Pennsylvania
Study officials:
affiliation: Harvard Pilgrim Health Care
name: Michael Klompas, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Klompas M, Anderson D, Trick W, Babcock H, Kerlin MP, Li L, Sinkowitz-Cochran R, Ely EW, Jernigan J, Magill S, Lyles R, O'Neil C, Kitch BT, Arrington E, Balas MC, Kleinman K, Bruce C, Lankiewicz J, Murphy MV, E Cox C, Lautenbach E, Sexton D, Fraser V, Weinstein RA, Platt R; CDC Prevention Epicenters. The preventability of ventilator-associated events. The CDC Prevention Epicenters Wake Up and Breathe Collaborative. Am J Respir Crit Care Med. 2015 Feb 1;191(3):292-301. doi: 10.1164/rccm.201407-1394OC.