Clinical trial Recruiting at 12 sites Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment200 (estimated)
SponsorOttawa Hospital Research Institute
Academic / other
Locations12 sites (Edmonton, Alberta and 11 other locations)
StatusRecruiting
StartedApril 22, 2024
Main results expectedSeptember 30, 2026
Study endsDecember 31, 2026
Registry record updatedApril 22, 2026
Trial IDNCT05506904 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.