CDC Prevention Epicenters Wake Up and Breathe Collaborative
Primary Purpose
Ventilator-associated Pneumonia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Daily SAT & SBT
Sponsored by
About this trial
This is an interventional treatment trial for Ventilator-associated Pneumonia focused on measuring Ventilator-associated pneumonia
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
Sites / Locations
- Chicago Prevention Epicenter
- North Shore Medical Center
- Washington University Prevention Epicenter
- Duke University Prevention Epicenter
- University of Pennsylvania Prevention Epicenter
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Opt Out Protocol
Arm Description
Outcomes
Primary Outcome Measures
Change in VAC rate.
A new definition for VAP is the primary focus of this study. This new definition (referred to as "streamlined VAP" or "sVAP") is under consideration by the CDC as a potential replacement for the current NHSN VAP definition and, as such, will be closely evaluated to determine if it can reflect meaningful changes in patient care. Thus, we will assess the change in monthly sVAP rates from study start to study end using an interrupted time series analysis.
Note that CDC released new surveillance definitions for ventilator-associated events in late 2012. Given that CDC definitions are the defacto surveillance standard, we switched the primary study outcome from sVAP to ventilator-associated conditions ("VAC"). All data elements required to assess for VAC were included in this study from the outset hence we did not have to collect any additional historical data in order to apply CDC's VAC definition.
Secondary Outcome Measures
ICU-specific outcomes
NHSN VAP rate
Mechanical ventilation days per patient
Ventilator-free days assessed over 28 days post-intubation
ICU length of stay per patient
Average antibiotic days
Rates of extubation and reintubation within 48 hours
Hospital-specific outcomes
Hospital length of stay
Hospital mortality
Patient-specific outcomes
Mean ventilator days
Mean ICU days
Mean hospital days
The above results will also be assessed separately for patients who received opt-out protocol care versus those who did not.
Full Information
NCT ID
NCT01583413
First Posted
April 20, 2012
Last Updated
October 10, 2013
Sponsor
Harvard Pilgrim Health Care
Collaborators
Centers for Disease Control and Prevention, Washington University School of Medicine, Rush University Medical Center, University of Pennsylvania, Duke University, North Shore Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01583413
Brief Title
CDC Prevention Epicenters Wake Up and Breathe Collaborative
Official Title
CDC Prevention Epicenters Wake Up and Breathe Collaborative
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard Pilgrim Health Care
Collaborators
Centers for Disease Control and Prevention, Washington University School of Medicine, Rush University Medical Center, University of Pennsylvania, Duke University, North Shore Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator-associated Pneumonia
Keywords
Ventilator-associated pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3342 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Opt Out Protocol
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Daily SAT & SBT
Intervention Description
Nurse and/or respiratory therapist led daily awakenings from sedation (spontaneous awakening trial, or SAT) and daily performance of a spontaneous breathing trial (SBT) among mechanically ventilated, critically ill patients in participating ICUs.
Primary Outcome Measure Information:
Title
Change in VAC rate.
Description
A new definition for VAP is the primary focus of this study. This new definition (referred to as "streamlined VAP" or "sVAP") is under consideration by the CDC as a potential replacement for the current NHSN VAP definition and, as such, will be closely evaluated to determine if it can reflect meaningful changes in patient care. Thus, we will assess the change in monthly sVAP rates from study start to study end using an interrupted time series analysis.
Note that CDC released new surveillance definitions for ventilator-associated events in late 2012. Given that CDC definitions are the defacto surveillance standard, we switched the primary study outcome from sVAP to ventilator-associated conditions ("VAC"). All data elements required to assess for VAC were included in this study from the outset hence we did not have to collect any additional historical data in order to apply CDC's VAC definition.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
ICU-specific outcomes
Description
NHSN VAP rate
Mechanical ventilation days per patient
Ventilator-free days assessed over 28 days post-intubation
ICU length of stay per patient
Average antibiotic days
Rates of extubation and reintubation within 48 hours
Time Frame
12-months
Title
Hospital-specific outcomes
Description
Hospital length of stay
Hospital mortality
Time Frame
12-months
Title
Patient-specific outcomes
Description
Mean ventilator days
Mean ICU days
Mean hospital days
The above results will also be assessed separately for patients who received opt-out protocol care versus those who did not.
Time Frame
12-months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Klompas, MD, MPH
Organizational Affiliation
Harvard Pilgrim Health Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chicago Prevention Epicenter
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
North Shore Medical Center
City
Salem
State/Province
Massachusetts
Country
United States
Facility Name
Washington University Prevention Epicenter
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Duke University Prevention Epicenter
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
University of Pennsylvania Prevention Epicenter
City
Philadelphia
State/Province
Pennsylvania
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25369558
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.
Results Reference
derived
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CDC Prevention Epicenters Wake Up and Breathe Collaborative
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