Airway ExtubationPhase 1NCT04708509
Extubation Advisor: Initial Implementation and Evaluation of a Novel Extubation Clinical Decision Support Tool
A Phase 1 study testing Extubation Advisor in people with Airway Extubation, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
Expeditious, safe extubation is vitally important in the care of Intensive Care Unit (ICU) patients, as prolonged mechanical ventilation harms patients and failed extubation (i.e. re-intubation within 48 hrs) is associated with increased morbidity, mortality and costs. 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
- 31 participants
- Where
- 1 siteCanada
- Study dates
- 4 Oct 2021to 13 Jan 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- In the Intensive Care Unit (ICU)
- Able to provide informed consent (through a surrogate)
- Invasive mechanical ventilation for > 48 hours
- Ready for spontaneous breathing test (SBT) for assessment for extubation
- At least partial reversal of the condition precipitating mechanical ventilation
- Stabilization of other organ systems
Show all 11Show fewer
- Toleration of pressure support ventilation less than or equal to 14 cm H2O, (oxygen saturation (SpO2) greater than or equal to 90% with fraction of inspired oxygen (FiO2) less than or equal to 40% and positive end-expiry pressure (PEEP) less than or equal to 10cm H2O)
- Hemodynamic stability (low - phenylephrine less than 50 ug/min; norepinephrine less than 5 ug/min; dobutamine less than 5 ug/kg/min; milrinone less than 0.4 ug/kg/min - or no vasopressors)
- Stable neurological status (no deterioration in Glasgow coma score during prior 24 hours and, if measured, intracranial pressure (ICP) less than 20 mmHg)
- Intact airway reflexes (adequate cough with suctioning and a gag reflex)
- Normal sinus rhythm at the time of the SBT (no pacemaker)
Who cannot join
- Order not to re-intubate should the patient fail extubation
- Anticipated withdrawal of life support
- Known or suspected severe weakness (myopathy, neuropathy, or quadriplegia)
- Tracheostomy
- Prior extubation during current ICU stay
Trial locations and contacts
1 site in 1 country.
About this study
Expeditious, safe extubation is vitally important in the care of Intensive Care Unit (ICU) patients, as prolonged mechanical ventilation harms patients and failed extubation (i.e. re-intubation within 48 hrs) is associated with increased morbidity, mortality and costs. The urgent need to improve extubation failure is further highlighted by current observations suggesting that COVID-19 patients are at increased risk of both early and late extubation failure. The investigators previously found that decreased respiratory rate variability (indicative of reduced adaptability and/or increased stress) during Spontaneous Breathing Trials (SBTs) predicted extubation failure and outperformed the best available predictive indices. Combining this predictive analytic with standardized extubation readiness checklists and risk mitigation strategies, the investigators created the Extubation Advisor (EA). The investigators recently completed a single-center phase I mixed methods observational study (n=117) wherein there was demonstrated technical feasibility (i.e. ability to generate 92% EA of reports) and clinician acceptance of the EA tool. In the current open-label, multi-center interventional phase I study, the investigators will assess the feasibility and initial perceptions of EA implementation in the intensive care unit by (1) evaluating the feasibility of patient enrolment, data collection, and EA report generation, and (2) performing a mixed-methods analysis of critical care physician and respiratory therapist perceptions of EA. Findings from this study will inform a future randomized controlled trial assessing EA outcomes compared to standard of care, with the intent of aiding bedside decision-making, enhancing care delivery, and improving outcomes in critically ill patients with and without COVID-19.
- 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. Patients will be followed for 72 hours after extubation, when the clinical outcome case report form will be completed.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate Feasibility of Enrolling and Consenting Greater Than 50% of Eligible Patients
Feasibility of patient enrolment and consent will be evaluated by determining if greater than 50% of eligible patients are enrolled and consented
Measured: Upon study completion, 4 months after study initiation
Evaluate Feasibility of Capturing Greater Than 75% of Wave Form Data
Feasibility of wave form data capture will be evaluated by determining if greater than 75% of the time, wave form data is captured
Measured: Upon study completion, 4 months after study initiation
Evaluate Feasibility of Generating and Delivering Greater Than 80% of Extubation Advisor Reports to the Attending Physician
Feasibility of Extubation Advisor report generation will be evaluated by determining if greater than 80% of the time, an extubation report is successfully generated and delivered to the attending physician
Measured: Upon study completion, 4 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 posted14 Jan 2021
- Study start4 Oct 2021
- Primary completion13 Jan 2023
- Study completion13 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label, multi-center interventional Phase 1 study to implement and evaluate perceptions of Extubation Advisor in consenting patients in the intensive care unit.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew JE Seely, MD, PhD, FRCSC, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708509
- Sponsor's protocol ID
- 2681
- Status last verified
- May 2025
- First submitted
- 11 Jan 2021
- Last updated
- 15 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hryciw BN, Hudek N, Brehaut JC, Herry C, Scales N, Lee E, Sarti AJ, Burns KEA, Seely AJE. Extubation Advisor: Implementation and Evaluation of A Novel Extubation Clinical Decision Support Tool. J Intensive Care Med. 2025 Apr;40(4):418-426. doi: 10.1177/08850666241291524. Epub 2024 Oct 24.
PubMed 39444331
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extubation Advisor: Initial Implementation and Evaluation of a Novel Extubation Clinical Decision Support Tool
- ClinicalTrials.gov ID
- NCT04708509
- Acronym / sponsor ID
- 2681
- Conditions
- Airway Extubation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 13 Jan 2023 (actual)
- Study completion
- 13 Jan 2023 (actual)
- First posted
- 14 Jan 2021 (actual)
- Results
- Posted 15 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Expeditious, safe extubation is vitally important in the care of Intensive Care Unit (ICU) patients, as prolonged mechanical ventilation harms patients and failed extubation (i.e. re-intubation within 48 hrs) is associated with increased morbidity, mortality and costs. The urgent need to improve extubation failure is further highlighted by current observations suggesting that COVID-19 patients are at increased risk of both early and late extubation failure. The investigators previously found that decreased respiratory rate variability (indicative of reduced adaptability and/or increased stress) during Spontaneous Breathing Trials (SBTs) predicted extubation failure and outperformed the best available predictive indices. Combining this predictive analytic with standardized extubation readiness checklists and risk mitigation strategies, the investigators created the Extubation Advisor (EA). The investigators recently completed a single-center phase I mixed methods observational study (n=117) wherein there was demonstrated technical feasibility (i.e. ability to generate 92% EA of reports) and clinician acceptance of the EA tool. In the current open-label, multi-center interventional phase I study, the investigators will assess the feasibility and initial perceptions of EA implementation in the intensive care unit by (1) evaluating the feasibility of patient enrolment, data collection, and EA report generation, and (2) performing a mixed-methods analysis of critical care physician and respiratory therapist perceptions of EA. Findings from this study will inform a future randomized controlled trial assessing EA outcomes compared to standard of care, with the intent of aiding bedside decision-making, enhancing care delivery, and improving outcomes in critically ill patients with and without COVID-19.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, multi-center interventional Phase 1 study to implement and evaluate perceptions of Extubation Advisor in consenting patients in the intensive care unit.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- In the Intensive Care Unit (ICU)
- Able to provide informed consent (through a surrogate)
- Invasive mechanical ventilation for > 48 hours
- Ready for spontaneous breathing test (SBT) for assessment for extubation
- At least partial reversal of the condition precipitating mechanical ventilation
Key exclusion criteria (5 listed)
- Order not to re-intubate should the patient fail extubation
- Anticipated withdrawal of life support
- Known or suspected severe weakness (myopathy, neuropathy, or quadriplegia)
- Tracheostomy
- Prior extubation during current ICU stay
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. Patients will be followed for 72 hours after extubation, when the clinical outcome case report form will be completed. | Device | Intervention Arm |
Primary outcome
Evaluate Feasibility of Enrolling and Consenting Greater Than 50% of Eligible Patients
Time frame: Upon study completion, 4 months after study initiation
Feasibility of patient enrolment and consent will be evaluated by determining if greater than 50% of eligible patients are enrolled and consented
Evaluate Feasibility of Capturing Greater Than 75% of Wave Form Data
Time frame: Upon study completion, 4 months after study initiation
Feasibility of wave form data capture will be evaluated by determining if greater than 75% of the time, wave form data is captured
Evaluate Feasibility of Generating and Delivering Greater Than 80% of Extubation Advisor Reports to the Attending Physician
Time frame: Upon study completion, 4 months after study initiation
Feasibility of Extubation Advisor report generation will be evaluated by determining if greater than 80% of the time, an extubation report is successfully generated and delivered to the attending physician
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39444331Hryciw BN, Hudek N, Brehaut JC, Herry C, Scales N, Lee E, Sarti AJ, Burns KEA, Seely AJE. Extubation Advisor: Implementation and Evaluation of A Novel Extubation Clinical Decision Support Tool. J Intensive Care Med. 2025 Apr;40(4):418-426. doi: 10.1177/08850666241291524. Epub 2024 Oct 24.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Andrew JE Seely, MD, PhD, FRCSC principal investigator
The Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Extubation Advisor in people with Airway Extubation, run by Ottawa Hospital Research Institute at 1 site 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 11 inclusion and 5 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: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate Feasibility of Enrolling and Consenting Greater Than 50% of Eligible Patients (time frame: Upon study completion, 4 months after study initiation). The study lists 3 primary outcomes in all. 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 NCT04708509, 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 15 May 2025; AzTrials last refreshed its copy on 30 Oct 2026.