Airway ExtubationLEADSNCT05506904
Liberation From Mechanical Ventilation Using Extubation Advisor Decision Support
A study testing Extubation Advisor in people with Airway Extubation, run by Ottawa Hospital Research Institute at 12 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Extubation
- What is being tested?
- Extubation Advisor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 12 sitesCanada
- Study dates
- 22 Apr 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Karen Burns, MD MSc FRCPC contact
12 sites in 1 country
Canada12 sites, 12 recruiting
- Recruiting
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9
Demetrios J Kutsogiannis, MD MHS FRCPC
Demetrios J Kutsogiannis, MD MHS FRCPC
- Recruiting
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
David Maslove, MD MS FRCPC
David Maslove, MD MS FRCPC
- Recruiting
Hotel Dieu de Levis
Lévis, Quebec, G6V 3Z1
Patrick Archambault, MD FRCPC
Patrick Archambault, MD FRCPC
- Recruiting
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 3E4
Emmanuel Charbonney, MD PhD
Emmanuel Charbonney, MD PhD
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Andrew JE Seely, MD PhD FRCSC, 613-737-8899 ext. 75052, aseely@toh.ca
Alexander Tran, MD FRCPC
- Recruiting
Queensway Carleton Hospital
Ottawa, Ontario, K2H 8P4
Akshai M Iyengar, MSc MD FRCPC
Akshai M Iyengar, MSc MD FRCPC
- Recruiting
Hopital de l'Enfant Jesus
Québec, Quebec, G1J 1Z4
Alexis F Turgeon, MD, MSc, FRCPC
Alexis F Turgeon, MD, MSc, FRCPC
- Recruiting
Institut universitaire de cardiologie et de pneumologie de Québec
Ste-Foy, Quebec, G1V 4G5
Francois Lellouche, MD PhD FRCPC
Francois Lellouche, MD PhD FRCPC
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Damon Scales, MD PhD FRCPC
Damon Scales, MD PhD FRCPC
- Recruiting
Unity Health Toronto - St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Karen Burns, MD MSc FRCPC, karen.burns@unityhealth.to
Karen Burns, MD MSc FRCPC
- Recruiting
St. Boniface Hospital
Winnipeg, Manitoba, R2H 2A6
Owen Mooney, MD FRCPC
Owen Mooney, MD FRCPC
- Recruiting
Health Sciences Centre Winnipeg
Winnipeg, Manitoba, R3A 1R9
Asher Mendelson, MD PhD FRCPC
Asher Mendelson, MD PhD FRCPC
About this study
Official title: Liberation From Mechanical Ventilation Using Extubation Advisor Decision Support: The Multicentre (LEADS) Pilot Trial
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).
Read more
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.
Read the detailed description
Background: Timely and safe extubation (i.e. endotracheal tube removal) in critically ill patients is vitally important as prolonged mechanical ventilation and failed attempts at extubation (i.e. re-intubation<48 hrs; 15% incidence) 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 the intensive care unit. In a prior multicenter study (n=721), 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 (n=117; 2 ICUs), 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).
Proposed Trial: The investigators will conduct the Liberation from mechanical ventilation using EA Decision Support (LEADS) Pilot Trial to assess feasibility outcomes including recruitment of critically ill patients with and without COVID-19 and protocol adherence.
Patients: The investigators will include critically ill adults who are invasively ventilated for >48 hours and who are ready to undergo an SBT with a view to extubation.
Intervention: Patients in the intervention arm will 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, rather than direct extubation decision-making by MDs.
Control: Patients in the control arm will receive standard care. SBTs will be directed by clinicians, using current best evidence. No EA assessments will be made, and no EA reports will be generated.
Outcomes: The primary feasibility outcome will reflect the ability to recruit the desired population. Secondary feasibility outcomes will assess rates of (i) consent (for eligible patients approached), (ii) randomization, (iii) intervention adherence, (iv) crossovers (EA to standard care and standard care to EA), and (v) completeness of clinical outcomes collected. 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 on average. The investigators aim to achieve >75% consent rate, >95% randomization rate in consented patients, >80% of EA reports generated and delivered (intervention arm), <10% crossovers (both arms), and >90% of patients with complete clinical outcomes. The investigators will report feasibility outcomes overall and by site.
Impact: The LEADS trial was informed by extensive preparatory work conducted within two parallel programs of research on weaning and extubation. 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
- Being tested
- Extubation Advisor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extubation AdvisorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Extubation Advisor |
| Standard of Care Arm | No intervention | Participants will undergo SBTs as directed by clinicians. The EA device will not be used. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Upon study completion, 12 months after study initiation
Secondary outcomes (9)
Evaluate feasibility of consenting greater than 75% of eligible patients
Feasibility of consenting eligible patients will be evaluated by determining if greater than 75% of eligible patients are consented to participate.
Measured: Upon study completion, 12 months after study initiation
Evaluate feasibility of randomizing greater the 95% of consented patients
Feasibility of randomizing consented patients will be evaluated by determining if greater than 95% of consented patients are randomized to either the intervention or standard of care arm.
Measured: Upon study completion, 12 months after study initiation
Evaluate feasibility of generating and delivering greater than 80% of EA reports to the attending physician
Feasibility of EA report generation will be evaluated by determining if greater than 80% of the time, EA reports are generated and delivered to the attending physician.
Measured: 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
Feasibility of limiting crossovers will be evaluated by determining if crossovers between the intervention and control arms occur less than 10% of the time.
Measured: Upon study completion, 12 months after study initiation
Evaluate feasibility of collecting complete patient outcomes greater than 90% of the time
Feasibility of collecting complete patient outcomes will be evaluated by determining if complete patient outcomes are collected greater than 90% of the time.
Measured: Upon study completion, 12 months after study initiation
Evaluate usefulness of EA reports
Usefulness of EA reports will be evaluated by MDs using a Likert scale (1-6) and be evaluated overall, by centre, by MD experience, and by MD gender. The minimum value of the scale (1) will be "not useful" and the maximum value of the scale (6) will be "very useful", with a higher value indicating a more positive opinion of the EA report.
Measured: Upon study completion, 12 months after study initiation
Evaluate institutional costs required to implement the EA device
The institutional costs required to implement the EA device will be evaluated by collecting institutional costs.
Measured: Upon study completion, 12 months after study initiation
Evaluate the time required by respiratory therapists to implement the EA device
The time required by respiratory therapists to implement the EA device will be evaluated by collecting the amount of time respiratory therapist spend implementing the EA device.
Measured: Upon study completion, 12 months after study initiation
Evaluate the time required by research coordinators to implement the EA device
The time required by research coordinators to implement the EA device will be evaluated by collecting the amount of time research coordinators spend implementing the EA device.
Measured: Upon study completion, 12 months after study initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start22 Apr 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Airway ExtubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen Burns, MD PhD FRCSC, Principal investigator, Unity Health Toronto - St. Michael's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506904
- Sponsor's protocol ID
- EA-LEADS-001
- Acronym
- LEADS
- Status last verified
- Apr 2026
- First submitted
- 2 Aug 2022
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The authors will make the trial data available in a de-identified format upon submission, review and approval of a written request and study outline. This may include all IPD that underlie results in a publication.
Publications
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.
PubMed 40107679
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liberation From Mechanical Ventilation Using Extubation Advisor Decision Support: The Multicentre (LEADS) Pilot Trial
- ClinicalTrials.gov ID
- NCT05506904
- Acronym / sponsor ID
- LEADS / EA-LEADS-001
- Conditions
- Airway Extubation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: Timely and safe extubation (i.e. endotracheal tube removal) in critically ill patients is vitally important as prolonged mechanical ventilation and failed attempts at extubation (i.e. re-intubation<48 hrs; 15% incidence) 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 the intensive care unit. In a prior multicenter study (n=721), 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 (n=117; 2 ICUs), 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).
Proposed Trial: The investigators will conduct the Liberation from mechanical ventilation using EA Decision Support (LEADS) Pilot Trial to assess feasibility outcomes including recruitment of critically ill patients with and without COVID-19 and protocol adherence.
Patients: The investigators will include critically ill adults who are invasively ventilated for >48 hours and who are ready to undergo an SBT with a view to extubation.
Intervention: Patients in the intervention arm will 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, rather than direct extubation decision-making by MDs.
Control: Patients in the control arm will receive standard care. SBTs will be directed by clinicians, using current best evidence. No EA assessments will be made, and no EA reports will be generated.
Outcomes: The primary feasibility outcome will reflect the ability to recruit the desired population. Secondary feasibility outcomes will assess rates of (i) consent (for eligible patients approached), (ii) randomization, (iii) intervention adherence, (iv) crossovers (EA to standard care and standard care to EA), and (v) completeness of clinical outcomes collected. 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 on average. The investigators aim to achieve >75% consent rate, >95% randomization rate in consented patients, >80% of EA reports generated and delivered (intervention arm), <10% crossovers (both arms), and >90% of patients with complete clinical outcomes. The investigators will report feasibility outcomes overall and by site.
Impact: The LEADS trial was informed by extensive preparatory work conducted within two parallel programs of research on weaning and extubation. 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Extubation Advisor | Experimental | Device: Extubation AdvisorWave 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. |
| Standard of Care Arm | No intervention | –Participants will undergo SBTs as directed by clinicians. The EA device will not be used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extubation AdvisorParticipants 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. | Device | Extubation Advisor |
Primary outcome
Evaluate the feasibility of enrolling 1-2 patients per centre per month
Time frame: Upon study completion, 12 months after study initiation
Feasibility of patient enrolment will be evaluated by determining if 1-2 patients are enrolled per centre per month.
9 secondary outcomes
Evaluate feasibility of consenting greater than 75% of eligible patients
Time frame: Upon study completion, 12 months after study initiation
Evaluate feasibility of randomizing greater the 95% of consented patients
Time frame: Upon study completion, 12 months after study initiation
Evaluate feasibility of generating and delivering greater than 80% of EA reports to the attending physician
Time frame: 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
Time frame: Upon study completion, 12 months after study initiation
Evaluate feasibility of collecting complete patient outcomes greater than 90% of the time
Time frame: Upon study completion, 12 months after study initiation
Evaluate usefulness of EA reports
Time frame: Upon study completion, 12 months after study initiation
Evaluate institutional costs required to implement the EA device
Time frame: Upon study completion, 12 months after study initiation
Evaluate the time required by respiratory therapists to implement the EA device
Time frame: Upon study completion, 12 months after study initiation
Evaluate the time required by research coordinators to implement the EA device
Time frame: Upon study completion, 12 months after study initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Derived from this study: PubMed 40107679Burns 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.
- Individual participant dataSharing planned: Yes. The authors will make the trial data available in a de-identified format upon submission, review and approval of a written request and study outline. This may include all IPD that underlie results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karen Burns, MD MSc FRCPC contact
Karen Burns, MD PhD FRCSC principal investigator
Unity Health Toronto - St. Michael's Hospital
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extubation Advisor in people with Airway Extubation, run by Ottawa Hospital Research Institute at 12 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew JE Seely, MD PhD FRCSC (613-737-8899 ext. 74052, aseely@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the feasibility of enrolling 1-2 patients per centre per month (time frame: Upon study completion, 12 months after study initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05506904, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026; AzTrials last refreshed its copy on 31 Oct 2026.