Liberation From Mechanical Ventilation Using Extubation Advisor Decision Support

Recruiting now · Not applicable

Conditions studied: Airway Extubation

In brief

Timely and safe extubation in critically ill patients is vitally important as prolonged mechanical ventilation and failed attempts at extubation are associated with increased morbidity, mortality, costs, intensive care unit (ICU) stays, and a risk for aerosolization of COVID-19 to health care providers. A Spontaneous Breathing Trial (SBT) is the current standard of care to assess a patient's readiness for extubation. However, SBTs are performed in various ways and have poor ability to predict successful extubation on their own. There is an urgent need to improve and standardize extubation decision-making. In a prior multicenter study, the investigators showed that decreased respiratory rate variability during SBTs predicted extubation failure better than other predictive indices. The Extubation Advisor (EA) tool combines clinician's assessments of extubation readiness with predictive analytics and risk mitigation strategies for individual patients. In a single centre observational study, the investigators demonstrated the ability to deliver EA reports to the bedside and acceptability of this decision-support tool to respiratory therapists (RTs) and physicians (MDs). The investigators will conduct the Liberation from mechanical ventilation using EA Decision Support (LEADS) Pilot Trial to assess feasibility outcomes. They will include critically ill adults who are invasively ventilated for \>48 hours and are ready to undergo an SBT. Patients in the intervention arm undergo an EA assessment and treating clinicians (RTs, MDs) will receive an EA report for each SBT conducted. The EA report will help to guide extubation decision-making. Patients in the control arm receive standard care. SBTs will be directed by clinicians. The primary feasibility outcome will reflect the ability to recruit the desired population. The investigators will also assess the usefulness of the tool to MDs and complete an analysis of resource utilization to inform future economic analyses of cost-effectiveness. The investigators aim to recruit 1 to 2 patients/month/center. The LEADS trial is novel and low-risk. It is the first trial to evaluate use of a bedside decision support tool to assist ICU clinicians with extubation decision-making. The LEADS pilot trial will inform the design of a future, large-scale randomized controlled trial that is expected to enhance the care delivered to critically ill patients, improve extubation outcomes, and inform extubation practice in ICUs.

Key facts

Study ID: NCT05506904
Run by: Ottawa Hospital Research Institute
People needed: 200
Starts: 2024-04-22
Expected to finish: 2026-12-31
Last updated by the study team: 2026-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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 is running

Royal Alexandra Hospital — Edmonton, Alberta, Canada (enrolling)
St. Boniface Hospital — Winnipeg, Manitoba, Canada (enrolling)
Health Sciences Centre Winnipeg — Winnipeg, Manitoba, Canada (enrolling)
Kingston Health Sciences Centre — Kingston, Ontario, Canada (enrolling)
The Ottawa Hospital — Ottawa, Ontario, Canada (enrolling)
Queensway Carleton Hospital — Ottawa, Ontario, Canada (enrolling)
Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (enrolling)
Unity Health Toronto - St. Michael's Hospital — Toronto, Ontario, Canada (enrolling)
Hotel Dieu de Levis — Lévis, Quebec, Canada (enrolling)
Centre hospitalier de l'Université de Montréal (CHUM) — Montreal, Quebec, Canada (enrolling)
Hopital de l'Enfant Jesus — Québec, Quebec, Canada (enrolling)
Institut universitaire de cardiologie et de pneumologie de Québec — Ste-Foy, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

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