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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01583413
Other study ID # PH000410A-2
Secondary ID 3U54CK000172-01S
Status Completed
Phase N/A
First received April 20, 2012
Last updated October 10, 2013
Start date May 2012
Est. completion date October 2013

Study information

Verified date October 2013
Source Harvard Pilgrim Health Care
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 3342
Est. completion date October 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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.

Locations

Country Name City State
United States Chicago Prevention Epicenter Chicago Illinois
United States Duke University Prevention Epicenter Durham North Carolina
United States University of Pennsylvania Prevention Epicenter Philadelphia Pennsylvania
United States North Shore Medical Center Salem Massachusetts
United States Washington University Prevention Epicenter St. Louis Missouri

Sponsors (7)

Lead Sponsor Collaborator
Harvard Pilgrim Health Care Centers for Disease Control and Prevention, Duke University, North Shore Medical Center, Rush University Medical Center, University of Pennsylvania, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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
12-months No
Secondary Hospital-specific outcomes Hospital length of stay
Hospital mortality
12-months No
Secondary 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.
12-months No
See also
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