Liberation from mechanical ventilation using Extubation Advisor Decision Support (LEADS): protocol for a multicentre pilot trial.
Karen E A Burns, Jill E Allan, Emma Lee...
https://pubmed.ncbi.nlm.nih.gov/40107679Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05506904
Liberation From Mechanical Ventilation Using Extubation Advisor Decision Support: The Multicentre (LEADS) Pilot Trial
Led by Ottawa Hospital Research Institute · Updated on 2026-04-22
200
Participants Needed
12
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying critically ill adult patients who have been on invasive mechanical ventilation for more than 48 hours and are ready to undergo a Spontaneous Breathing Trial (SBT) to assess readiness for extubation. The study aims to improve and standardize decision-making for extubation in intensive care units by evaluating the Extubation Advisor (EA), a bedside decision support tool that combines clinician assessments with predictive analytics to better predict extubation success and failure. This pilot trial will assess the feasibility of using the EA tool and inform a future larger randomized controlled trial to enhance extubation care and outcomes. In this randomized, single-blind trial, patients in the intervention group undergo an EA assessment during their SBTs. The device records waveform data and patient information, then generates a report that helps respiratory therapists and physicians decide whether to proceed with extubation. Patients in the control group receive standard care, with SBTs directed by clinicians without EA assessments or reports. The trial will assess recruitment feasibility, adherence to the protocol, and resource use over about 12 months. Participants will be monitored with assessments including the generation and delivery of EA reports and collection of clinical outcomes until hospital discharge. Researchers will evaluate the trial's success based on recruitment rates, consent and randomization rates, adherence to intervention protocols, crossover occurrences, and completeness of clinical data. They will also assess the usefulness of the EA reports and measure institutional costs and time needed to implement the device. The study duration per participant varies according to clinical care and hospital stay.
CONDITIONS
Brief Title
Liberation From Mechanical Ventilation Using Extubation Advisor Decision Support
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Critically ill adults aged 18 years or older
- Receiving invasive mechanical ventilation for more than 48 hours
- Expected to undergo an initial Spontaneous Breathing Trial (SBT) within the next 48 hours to assess readiness for extubation as determined by treating physicians
- SBT defined as assessment on low ventilator settings such as T-piece, CPAP, or pressure support less than 8 cm H2O regardless of PEEP
You will not qualify if you...
- Known or suspected severe peripheral myopathy or neuropathy, limb weakness, paralysis, or central nervous system injury such as post-arrest or large stroke
- Glasgow Coma Scale less than 6
- Do not wish to be re-intubated as part of treatment goals
- Previously extubated during the same ICU admission
- Have undergone one or more documented SBTs with pressure support reduced to 8 or less in the 24 hours before randomization
- Already have a tracheostomy
- Moribund or expected to die
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Up to 48 hours until initial SBT and extubation decisions
Participants undergo Spontaneous Breathing Trials (SBTs) to assess readiness for extubation. In the intervention arm, waveform data during SBTs are analyzed by the Extubation Advisor device to generate reports that assist clinicians in extubation decision-making. Participants in the control arm receive standard care without the device.
1 to 2 visits depending on timing of SBTs
Long-term Monitoring
Duration - Up to hospital discharge
Participants are observed for clinical outcomes, including extubation success and any complications, until hospital discharge.
Assessments at hospital discharge
Trial Site Locations
Total: 12 locations
1
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9
Actively Recruiting
2
St. Boniface Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Actively Recruiting
3
Health Sciences Centre Winnipeg
Winnipeg, Manitoba, Canada, R3A 1R9
Actively Recruiting
4
Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L 2V7
Actively Recruiting
5
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
6
Queensway Carleton Hospital
Ottawa, Ontario, Canada, K2H 8P4
Actively Recruiting
7
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
8
Unity Health Toronto - St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Actively Recruiting
9
Hotel Dieu de Levis
Lévis, Quebec, Canada, G6V 3Z1
Actively Recruiting
10
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada, H2X 3E4
Actively Recruiting
11
Hopital de l'Enfant Jesus
Québec, Quebec, Canada, G1J 1Z4
Actively Recruiting
12
Institut universitaire de cardiologie et de pneumologie de Québec
Ste-Foy, Quebec, Canada, G1V 4G5
Actively Recruiting
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Research Team
A
Andrew JE Seely, MD PhD FRCSC
K
Karen Burns, MD MSc FRCPC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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