Improving extubation decisions for critically ill patients
Official title: Liberation From Mechanical Ventilation Using Extubation Advisor Decision Support: The Multicentre (LEADS) Pilot Trial
Run by Ottawa Hospital Research Institute · NCT05506904 · Data updated 2026-11-12
This study is testing a new tool to help doctors decide when critically ill patients are ready to be taken off breathing machines, aiming to improve their recovery and reduce risks.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Ottawa Hospital Research Institute Academic / other |
| Locations | 12 sites (Edmonton, Alberta and 11 other locations) |
| Status | Recruiting |
| Started | April 22, 2024 |
| Main results expected | September 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | April 22, 2026 |
| Trial ID | NCT05506904 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include critically ill adults aged 18 and older who are in the ICU and anticipated to require invasive ventilation for more than 48 hours.
✕Probably not a fit
Patients who do not wish to be re-intubated or have severe myopathy, neuropathy, or significant central nervous system injuries may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial aims to enhance the decision-making process for extubation in critically ill patients using the Extubation Advisor (EA) tool. The EA combines clinician assessments with predictive analytics to better determine a patient's readiness for extubation, addressing the limitations of current Spontaneous Breathing Trials (SBTs). The study will assess the feasibility of implementing this decision-support tool in intensive care units to improve patient outcomes and reduce the risks associated with prolonged mechanical ventilation. By standardizing extubation decision-making, the trial seeks to minimize complications and improve overall care for patients requiring invasive ventilation.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more timely extubation for critically ill patients, reducing morbidity and healthcare costs.
How similar studies have gone: Previous studies have shown promise in using predictive analytics for extubation decisions, indicating that this approach may build on existing knowledge rather than being entirely novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Critically ill adults (age≥18) * Invasive ventilation for \>48 hours * Who are expected to undergo an initial SBT within the next 48 hours with a view to extubation as per treating MDs. As per the FAST trial, an SBT will be defined as a focused assessment on low ventilator settings \[T-piece, continuous positive airway pressure (CPAP), or PS \< 8 cm H2O regardless of positive end-expiratory pressure (PEEP) Exclusion Criteria: * Suffer from known or suspected peripheral severe myopathy or neuropathy, or limb weakness or paralysis or central (e.g., post arrest, large intracranial stroke or bleed) injury or Glasgow Coma Scale (GCS) \< 6 * Do not wish to be re-intubated as part of their treatment goals * Were previously extubated during the same ICU admission * Have undergone 1 or more SBTs where the SBT was clearly documented in the chart and/or the PS was reduced to the SBT level of 8 or less during the 24 hour period prior to randomization * Already have a tracheostomy * Are moribund or expected to die.
Where it's running
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Royal Alexandra Hospital
Edmonton, Alberta, Canada Recruiting -
St. Boniface Hospital
Winnipeg, Manitoba, Canada Recruiting -
Health Sciences Centre Winnipeg
Winnipeg, Manitoba, Canada Recruiting -
Kingston Health Sciences Centre
Kingston, Ontario, Canada Recruiting -
The Ottawa Hospital
Ottawa, Ontario, Canada Recruiting -
Queensway Carleton Hospital
Ottawa, Ontario, Canada Recruiting
Show 6 more locations
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Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada Recruiting -
Unity Health Toronto - St. Michael's Hospital
Toronto, Ontario, Canada Recruiting -
Hotel Dieu de Levis
Lévis, Quebec, Canada Recruiting -
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada Recruiting -
Hopital de l'Enfant Jesus
Québec, Quebec, Canada Recruiting -
Institut universitaire de cardiologie et de pneumologie de Québec
Ste-Foy, Quebec, Canada Recruiting
Study contacts
- Principal investigator: Karen Burns, MD PhD FRCSC — Unity Health Toronto - St. Michael's Hospital
- Study coordinator: Andrew JE Seely, MD PhD FRCSC
- Email: aseely@toh.ca
- Phone: 613-737-8899
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.