Condition category
Respiratory
Date applied
03/01/2006
Date assigned
30/01/2006
Last edited
31/07/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Karen E. A. Burns

ORCID ID

Contact details

St Michael's Hospital
30 Bond street
3-075E Queen wing
Toronto
M5B 1W8
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

The WEAN Study

Study hypothesis

The primary objective of this multicentre pilot study is to compare automatic and protocolised weaning and to evaluate compliance with the proposed weaning and sedation protocols

Ethics approval

Not provided at time of registration

Study design

Multicentre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Weaning intubated adults from invasive mechanical ventilation

Intervention

Automatic (computer-driven) weaning versus protocolized weaning

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Compliance with the weaning and sedation protocols

Secondary outcome measures

1. Acceptance of the weaning and sedation protocols
2. Weaning and Intensive Care Unit (ICU) related-complications
3. Time to successful completion of a Single Breath Test (SBT) and extubation

Overall trial start date

30/05/2006

Overall trial end date

01/06/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Patients who are invasively ventilated for at least 24 hours

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

90

Participant exclusion criteria

1. Age < 16 years
2. Tracheotomy
3. Pregnancy
4. Do not intubate (DNI) or do not resuscitate (DNR) patients
5. Planned extubation on the day of study inclusion
6. Planned surgery or procedures within 48 hours of randomization

Recruitment start date

30/05/2006

Recruitment end date

01/06/2006

Locations

Countries of recruitment

Canada

Trial participating centre

St Michael's Hospital
Toronto
M5B 1W8
Canada

Sponsor information

Organisation

Physician Services Incorporated (Canada)

Sponsor details

5160 Yonge street
Suite 1006
Toronto
M2N 6L9
Canada

Sponsor type

Charity

Website

Funders

Funder type

Charity

Funder name

Physician Services Incorporated (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Draeger Canada (in kind)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19732444
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23525929

Publication citations

  1. Protocol

    Burns KE, Meade MO, Lessard MR, Keenan SP, Lellouche F, Wean Earlier and Automatically with New technology (the WEAN study): a protocol of a multicentre, pilot randomized controlled trial., Trials, 2009, 10, 81, doi: 10.1186/1745-6215-10-81.

  2. Results

    Burns KE, Meade MO, Lessard MR, Hand L, Zhou Q, Keenan SP, Lellouche F, Wean earlier and automatically with new technology (the WEAN study). A multicenter, pilot randomized controlled trial., Am. J. Respir. Crit. Care Med., 2013, 187, 11, 1203-1211, doi: 10.1164/rccm.201206-1026OC.

Additional files

Editorial Notes