Liberation From Mechanical Ventilation Using Extubation Advisor Decision Support

NCT05506904 | Recruiting DMC

• 1 other identifier: EA-LEADS-001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 12

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.

Conditions

Airway Extubation

Outcome Measures

Primary Outcomes (1)

• Evaluate the feasibility of enrolling 1-2 patients per centre per month

  Feasibility of patient enrolment will be evaluated by determining if 1-2 patients are enrolled per centre per month.

  Upon study completion, 12 months after study initiation

Secondary Outcomes (9)

• Evaluate feasibility of consenting greater than 75% of eligible patients

  Upon study completion, 12 months after study initiation

• Evaluate feasibility of randomizing greater the 95% of consented patients

  Upon study completion, 12 months after study initiation

• Evaluate feasibility of generating and delivering greater than 80% of EA reports to the attending physician

  Upon study completion, 12 months after study initiation

• Evaluate feasibility of crossovers between the intervention and control arms occurring less than 10% of the time

  Upon study completion, 12 months after study initiation

• Evaluate feasibility of collecting complete patient outcomes greater than 90% of the time

  Upon study completion, 12 months after study initiation

Study Arms (2)

Extubation Advisor

EXPERIMENTAL

Wave form data from participants' spontaneous breathing trials (SBT) will be analyzed using Extubation Advisor (EA) to generate an EA report that provides clinical decision support regarding extubation.

Device: Extubation Advisor

Standard of Care Arm

NO INTERVENTION

Participants will undergo SBTs as directed by clinicians. The EA device will not be used.

Interventions

Extubation Advisor DEVICE

Participants undergoing a Spontaneous Breathing Trial (SBT) to assess readiness for extubation will be connected to a portable monitor displaying ECG, capnography, and other waveforms. This monitor will also be connected to a laptop containing the Extubation Advisor (EA) software. During the SBT, relevant patient information will be entered into the EA application and the EA application will record waveform data. When the SBT is complete, the EA application will analyze the waveform and patient data to generate a score summarizing the risk of extubation failure. A report will be generated and provided to the respiratory therapist and attending physician to help determine whether to proceed with extubation or not. The clinical outcome case report form will be completed at the time of hospital discharge.

Extubation Advisor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (12)

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

RECRUITING

St. Boniface Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

RECRUITING

Health Sciences Centre Winnipeg

Winnipeg, Manitoba, R3A 1R9, Canada

RECRUITING

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

RECRUITING

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Queensway Carleton Hospital

Ottawa, Ontario, K2H 8P4, Canada

RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Unity Health Toronto - St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

Hotel Dieu de Levis

Lévis, Quebec, G6V 3Z1, Canada

RECRUITING

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

Hopital de l'Enfant Jesus

Québec, Quebec, G1J 1Z4, Canada

RECRUITING

Institut universitaire de cardiologie et de pneumologie de Québec

Ste-Foy, Quebec, G1V 4G5, Canada

RECRUITING

Related Publications (1)

• Burns KEA, Allan JE, Lee E, Santos-Taylor M, Kay P, Greco P, Every H, Mooney O, Tanios M, Tan E, Herry CL, Scales NB, Gouskos A, Tran A, Iyengar A, Maslove DM, Kutsogiannis J, Charbonney E, Mendelson A, Lellouche F, Lamontagne F, Scales D, Archambault P, Turgeon AF, Seely AJE, Group CCCT. Liberation from mechanical ventilation using Extubation Advisor Decision Support (LEADS): protocol for a multicentre pilot trial. BMJ Open. 2025 Mar 18;15(3):e093853. doi: 10.1136/bmjopen-2024-093853.

  PMID: 40107679 DERIVED

Study Officials

• Karen Burns, MD PhD FRCSC

  Unity Health Toronto - St. Michael's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew JE Seely, MD PhD FRCSC

CONTACT

613-737-8899; aseely@toh.ca

Karen Burns, MD MSc FRCPC

CONTACT

karen.burns@unityhealth.to

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statisticians will be blinded to treatment assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicentre pragmatic vanguard pilot RCT of the EA tool in invasive ventilated critically ill patients, with and without COVID-19. Individual patients will be randomized (1:1) to intervention (EA tool) or control (standard care).

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 18, 2022
• Study Start: April 22, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: This information will be available 4 months after pilot trial completion (estimated Sep 2026) and for 5 years thereafter.
• Access Criteria: Data will be provided for secondary analyses or data syntheses ( e.g., meta-analyses) accompanied by a study protocol and ethics approval. The authors reserve the write to withhold data related to treatment allocation should the patients in the pilot trial be rolled forward into a larger trial. Drs. Burns and Seeky will review requests for access to deidentified data.

Locations

CA (12)