NCT00157287

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jun 2003

Typical duration for phase_3

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

August 25, 2017

Status Verified

August 1, 2017

Enrollment Period

2 years

First QC Date

September 8, 2005

Last Update Submit

August 24, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • ICU length of stay

Secondary Outcomes (7)

  • duration of ventilation

  • length of hospital stay

  • complications (re-intubation within 48 hours, pneumonia within 48 hours)

  • ICU mortality

  • Hospital mortality

  • +2 more secondary outcomes

Interventions

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients ventilated for more than 24 hours

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

William Osler Health Centre (Brampton)

Brampton, Ontario, N6W 2Z8, Canada

Location

Brant Community Health Systems

Brantford, Ontario, N3R 1G9, Canada

Location

Joseph Brant Memorial Hospital

Burlington, Ontario, L7R 4C4, Canada

Location

Guelph General Hospital

Guelph, Ontario, N1E 4J4, Canada

Location

St. Joseph's Health Care

London, Ontario, N6A 4V2, Canada

Location

Trillium Health Centre

Mississauga, Ontario, L5B 1B8, Canada

Location

North Bay General Hospital

North Bay, Ontario, P1B 5A4, Canada

Location

Lakeridge Health Corporation (Oshawa)

Oshawa, Ontario, L1G 2B9, Canada

Location

Stratford General Hospital

Stratford, Ontario, N5A 2Y6, Canada

Location

St. Joseph's Health Centre

Toronto, Ontario, M9R 1B5, Canada

Location

Hotel Dieu of St. Joseph

Windsor, Ontario, N9A 1E1, Canada

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ronald J Butler, MD

    London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    PRINCIPAL INVESTIGATOR
  • Claudio Martin, MD

    London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    PRINCIPAL INVESTIGATOR
  • Femida Gwadry-Sridhar, MSc

    London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

June 1, 2003

Primary Completion

June 1, 2005

Study Completion

April 1, 2006

Last Updated

August 25, 2017

Record last verified: 2017-08

Locations