Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

CDC Prevention Epicenters Wake Up and Breathe Collaborative

This study has been completed.
Sponsor:
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
Information provided by (Responsible Party):
Michael Klompas MD, MPH, FRCPC, Harvard Pilgrim Health Care
ClinicalTrials.gov Identifier:
NCT01583413
First received: April 20, 2012
Last updated: October 10, 2013
Last verified: October 2013
History of Changes
  Purpose

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.


Condition Intervention
Ventilator-associated Pneumonia
 Procedure: Daily SAT & SBT

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CDC Prevention Epicenters Wake Up and Breathe Collaborative

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Further study details as provided by Harvard Pilgrim Health Care:

Primary Outcome Measures:
  • Change in VAC rate. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: 12-months ] [ Designated as safety issue: No ]
    • 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 [ Time Frame: 12-months ] [ Designated as safety issue: No ]
    • Hospital length of stay
    • Hospital mortality

  • Patient-specific outcomes [ Time Frame: 12-months ] [ Designated as safety issue: No ]
    • 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.
Enrollment: 3342
Study Start Date: May 2012
Study Completion Date: October 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Opt Out Protocol Procedure: 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.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01583413

Locations
United States, Illinois
Chicago Prevention Epicenter
Chicago, Illinois, United States
United States, Massachusetts
North Shore Medical Center
Salem, Massachusetts, United States
United States, Missouri
Washington University Prevention Epicenter
St. Louis, Missouri, United States
United States, North Carolina
Duke University Prevention Epicenter
Durham, North Carolina, United States
United States, Pennsylvania
University of Pennsylvania Prevention Epicenter
Philadelphia, Pennsylvania, United States
Sponsors and Collaborators
Harvard Pilgrim Health Care
Centers for Disease Control and Prevention
Washington University School of Medicine
Rush University Medical Center
University of Pennsylvania
Duke University
North Shore Medical Center
Investigators
Principal Investigator: Michael Klompas, MD, MPH Harvard Pilgrim Health Care
  More Information

No publications provided

Responsible Party: Michael Klompas MD, MPH, FRCPC, Principal Investigator, Harvard Pilgrim Health Care
ClinicalTrials.gov Identifier: NCT01583413     History of Changes
Other Study ID Numbers: PH000410A-2, 3U54CK000172-01S1
Study First Received: April 20, 2012
Last Updated: October 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Harvard Pilgrim Health Care:
Ventilator-associated pneumonia

Additional relevant MeSH terms:
Pneumonia, Ventilator-Associated
Cross Infection
Infection
Lung Diseases
Lung Injury
 Pneumonia
Respiratory Tract Diseases
Respiratory Tract Infections
Ventilator-Induced Lung Injury

ClinicalTrials.gov processed this record on February 27, 2015