Respiration, ArtificialPhase 3NCT00157287
A Cluster Randomized Trial to Improve Weaning and Extubation From Mechanical Ventilation in Community Hospitals
A Phase 3 study testing Evidence based weaning protocol in people with Respiration, Artificial, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 11 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Respiration, Artificial
- What is being tested?
- Evidence based weaning protocol
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 11 sitesCanada
- Study dates
- Jun 2003to Apr 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients ventilated for more than 24 hours
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Canada11 sites
William Osler Health Centre (Brampton)
Brampton, Ontario, N6W 2Z8
Brant Community Health Systems
Brantford, Ontario, N3R 1G9
Joseph Brant Memorial Hospital
Burlington, Ontario, L7R 4C4
Guelph General Hospital
Guelph, Ontario, N1E 4J4
St. Joseph's Health Care
London, Ontario, N6A 4V2
Trillium Health Centre
Mississauga, Ontario, L5B 1B8
North Bay General Hospital
North Bay, Ontario, P1B 5A4
Lakeridge Health Corporation (Oshawa)
Oshawa, Ontario, L1G 2B9
Stratford General Hospital
Stratford, Ontario, N5A 2Y6
St. Joseph's Health Centre
Toronto, Ontario, M9R 1B5
Hotel Dieu of St. Joseph
Windsor, Ontario, N9A 1E1
About this study
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.
- Conditions
- Respiration, Artificial
- Being tested
- Evidence based weaning protocol
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evidence based weaning protocolProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
ICU readmissions
Qulaity of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJun 2003
- Primary completionJun 2005
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiration, ArtificialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronald J Butler, MD, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sClaudio Martin, MD, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sFemida Gwadry-Sridhar, MSc, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00157287
- Sponsor's protocol ID
- R-01-076
- Status last verified
- Aug 2017
- First submitted
- 8 Sep 2005
- Last updated
- 25 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomized Trial to Improve Weaning and Extubation From Mechanical Ventilation in Community Hospitals
- ClinicalTrials.gov ID
- NCT00157287
- Acronym / sponsor ID
- R-01-076
- Conditions
- Respiration, Artificial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Jun 2003
- Primary completion
- Jun 2005 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients ventilated for more than 24 hours
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evidence based weaning protocol | Procedure or surgery | – |
Primary outcome
ICU length of stay
7 secondary outcomes
duration of ventilation
length of hospital stay
complications (re-intubation within 48 hours, pneumonia within 48 hours)
ICU mortality
Hospital mortality
ICU readmissions
Qulaity of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald J Butler, MD principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Claudio Martin, MD principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Femida Gwadry-Sridhar, MSc principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Evidence based weaning protocol in people with Respiration, Artificial, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 11 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU length of stay. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2017.