A Cluster Randomized Trial to Improve Weaning and Extubation From Mechanical Ventilation in Community Hospitals

Protocol directed weaning has been shown to reduce the duration of mechanical ventilation for patients admitted to the intensive care unit (ICU) of tertiary centres. However, this benefit has not previously been studied in a community hospital setting. We therefore sought to evaluate the impact of an evidence-based weaning guideline on the outcomes for patients receiving mechanical ventilation in the ICUs of community hospitals in a cluster randomized controlled trial involving 11 community hospitals.

Study Overview

• Status: Completed
• Conditions: Respiration, Artificial
• Intervention / Treatment: Procedure: Evidence based weaning protocol

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Brampton, Ontario, Canada, N6W 2Z8
      • William Osler Health Centre (Brampton)
    • Brantford, Ontario, Canada, N3R 1G9
      • Brant Community Health Systems
    • Burlington, Ontario, Canada, L7R 4C4
      • Joseph Brant Memorial Hospital
    • Guelph, Ontario, Canada, N1E 4J4
      • Guelph General Hospital
    • London, Ontario, Canada, N6A 4V2
      • St. Joseph's Health Care
    • Mississauga, Ontario, Canada, L5B 1B8
      • Trillium Health Centre
    • North Bay, Ontario, Canada, P1B 5A4
      • North Bay General Hospital
    • Oshawa, Ontario, Canada, L1G 2B9
      • Lakeridge Health Corporation (Oshawa)
    • Stratford, Ontario, Canada, N5A 2Y6
      • Stratford General Hospital
    • Toronto, Ontario, Canada, M9R 1B5
      • St. Joseph's Health Centre
    • Windsor, Ontario, Canada, N9A 1E1
      • Hotel Dieu of St. Joseph

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients ventilated for more than 24 hours

Exclusion Criteria:

• patients less than 16 years of age patients who receive only non-invasive ventilation patients chronically ventilated at time of ICU admission patients who will not be candidates for weaning from ventilation at time of admission If withdrawl of life support is imminent at the point the patient has been ventilated for 24 hours

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
ICU length of stay

Secondary Outcome Measures

Outcome Measure
ICU mortality
length of hospital stay
Hospital mortality
duration of ventilation
complications (re-intubation within 48 hours, pneumonia within 48 hours)
ICU readmissions
Qulaity of life

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Ronald J Butler, MD, Lawson Health Research Institute; Principal Investigator: Claudio Martin, MD, Lawson Health Research Institute; Principal Investigator: Femida Gwadry-Sridhar, MSc, Lawson Health Research Institute

Study record dates

Study Major Dates

• Study Start: June 1, 2003
• Primary Completion (Actual): June 1, 2005
• Study Completion (Actual): April 1, 2006

Study Registration Dates

• First Submitted: September 8, 2005
• First Submitted That Met QC Criteria: September 8, 2005
• First Posted (Estimate): September 12, 2005

Study Record Updates

• Last Update Posted (Actual): August 25, 2017
• Last Update Submitted That Met QC Criteria: August 24, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: R-01-076

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No