Skip to main content
OpenTrials
Completed

NCT Number: NCT01583413

CDC Prevention Epicenters Wake Up and Breathe Collaborative

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chicago Prevention Epicenter, Chicago, Illinois, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in VAC rate.

    Time frame: 12 months

    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 outcomes

  1. ICU-specific outcomes

    Time frame: 12-months

    • 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

  2. Hospital-specific outcomes

    Time frame: 12-months

    • Hospital length of stay
    • Hospital mortality

  3. Patient-specific outcomes

    Time frame: 12-months

    • 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.

Sponsors and collaborators

Lead sponsor

Harvard Pilgrim Health Care

Other

Collaborators

  • Centers for Disease Control and Prevention
  • Duke University
  • North Shore Medical Center
  • Rush University Medical Center
  • University of Pennsylvania
  • Washington University School of Medicine

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 24, 2012
Registry last updated
Oct 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.