CDC Prevention Epicenters Wake Up and Breathe Collaborative

NCT01583413 | Completed

• 2 other identifiers: PH000410A-23U54CK000172-01S1
• Study Type: interventional
• Target: 3,342
• Locations: 1 country
• Sites: 5

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.

Conditions

Ventilator-associated Pneumonia

Keywords

Ventilator-associated pneumonia

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (3)

• ICU-specific outcomes

  12-months

• Hospital-specific outcomes

  12-months

• Patient-specific outcomes

  12-months

Study Arms (1)

Opt Out Protocol

EXPERIMENTAL

Procedure: Daily SAT & SBT

Interventions

Daily SAT & SBT PROCEDURE

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.

Opt Out Protocol

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• moribund status or plans for withdrawal of life support

Sponsors & Collaborators

• Harvard Pilgrim Health Care: lead
• Centers for Disease Control and Prevention: collaborator
• Washington University School of Medicine: collaborator
• Rush University Medical Center: collaborator
• University of Pennsylvania: collaborator
• Duke University: collaborator
• North Shore Medical Center: collaborator

Study Sites (5)

Chicago Prevention Epicenter

Chicago, Illinois, United States

Location

North Shore Medical Center

Salem, Massachusetts, United States

Location

Washington University Prevention Epicenter

St Louis, Missouri, United States

Location

Duke University Prevention Epicenter

Durham, North Carolina, United States

Location

University of Pennsylvania Prevention Epicenter

Philadelphia, Pennsylvania, United States

Location

Related Publications (1)

• 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.

  PMID: 25369558 DERIVED

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Serum Bactericidal Test

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Microbial Sensitivity Tests; Microbiological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Drug Evaluation, Preclinical; Evaluation Studies as Topic

Study Officials

• Michael Klompas, MD, MPH

  Harvard Pilgrim Health Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 20, 2012
• First Posted: April 24, 2012
• Study Start: May 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 11, 2013

Record last verified: 2013-10

Locations

US (5)