NCT05506904 Liberation From Mechanical Ventilation Using Extubation Advisor Decision Support
| NCT ID | NCT05506904 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ottawa Hospital Research Institute |
| Condition | Airway Extubation |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-04-22 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2024-04-22 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Karen Burns, MD PhD FRCSC
PRINCIPAL INVESTIGATOR
Unity Health Toronto - St. Michael's Hospital
Frequently Asked Questions
Who can join the NCT05506904 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Airway Extubation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05506904 currently recruiting?
Yes, NCT05506904 is actively recruiting participants. Contact the research team at aseely@toh.ca for enrollment information.
Where is the NCT05506904 trial being conducted?
This trial is being conducted at Edmonton, Canada, Winnipeg, Canada, Winnipeg, Canada, Kingston, Canada and 8 additional locations.
Who is sponsoring the NCT05506904 clinical trial?
NCT05506904 is sponsored by Ottawa Hospital Research Institute. The principal investigator is Karen Burns, MD PhD FRCSC at Unity Health Toronto - St. Michael's Hospital. The trial plans to enroll 200 participants.