Improving extubation decisions for critically ill patients
Liberation From Mechanical Ventilation Using Extubation Advisor Decision Support: The Multicentre (LEADS) Pilot Trial
NA · Ottawa Hospital Research Institute · NCT05506904
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ottawa Hospital Research Institute (other) |
| Locations | 12 sites (Edmonton, Alberta and 11 other locations) |
| Trial ID | NCT05506904 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Edmonton, Alberta and 11 other locations
- 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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Airway Extubation