CDC Prevention Epicenters Wake Up and Breathe Collaborative

NCT ID: NCT01583413

Last Updated: 2013-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3342 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ventilator-associated Pneumonia

Keywords

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Ventilator-associated pneumonia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Opt Out Protocol

Group Type EXPERIMENTAL

Daily SAT & SBT

Intervention Type 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.

Interventions

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Daily SAT & SBT

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role collaborator

Rush University Medical Center

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role collaborator

North Shore Medical Center

OTHER

Sponsor Role collaborator

Harvard Pilgrim Health Care

OTHER

Sponsor Role lead

Responsible Party

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Michael Klompas MD, MPH, FRCPC

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Klompas, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Harvard Pilgrim Health Care

Locations

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Chicago Prevention Epicenter

Chicago, Illinois, United States

Site Status

North Shore Medical Center

Salem, Massachusetts, United States

Site Status

Washington University Prevention Epicenter

St Louis, Missouri, United States

Site Status

Duke University Prevention Epicenter

Durham, North Carolina, United States

Site Status

University of Pennsylvania Prevention Epicenter

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 25369558 (View on PubMed)

Other Identifiers

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3U54CK000172-01S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PH000410A-2

Identifier Type: -

Identifier Source: org_study_id