Patient SimulationNCT03054272
Visual Perception Exploration Using Eye-tracking Technology in a Cannot Intubate/Cannot Oxygenate Simulation
An observational study of Patient Simulation and Perception, run by Université de Montréal.
Trial summary
Using eye-tracking technology, the aim of this observational study is to compare the visual interests between attending physicians and residents watching a Cannot Intubate/Cannot Oxygenate (CICO) scripted and simulated scenario Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Patient Simulation, Perception, Intubation; Difficult or Failed
- What is being tested?
- Video
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 1 Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Residents and attending physicians from University of Montreal Anesthesia Department
Who may be able to join
- Residents and attending physicians from University of Montreal Anesthesia Department
Who cannot join
- None
About this study
Using eye-tracking technology, the aim of this observational study is to compare the visual interests between attending physicians and residents watching a Cannot Intubate/Cannot Oxygenate (CICO) scripted and simulated scenario
Read the detailed description
Attending physicians and residents, from the department of Anesthesiology at the Université de Montréal were recruited on a voluntary basis. A 13-minute video based on a suggested CICO algorithm from the Difficult Airway Society to manage unanticipated difficult intubation in adults (3) was produced at the University of Montreal Simulation Centre using high-fidelity settings. The scenario was about a patient, with a cervical collar, in the post-anesthesia care unit. Throughout the video, the patient presents increasing respiratory distress worsening to respiratory failure. The anesthesiologist fails to ventilate, intubate and insert a laryngeal mask leading to a cricothyroidotomy. All participants were looking at a screen on which the scenario was broadcast. The screen was equipped with TobiiEyeX®, an eye-tracking system that automatically aggregates gaze data.
- Being tested
- Video
- Keywords
- High-fidelity simulation, Eye-tracking, Difficult intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideoBehavioural
A 13-minute video based on a suggested CICO algorithm from the Difficult Airway Society that was produced at the University of Montreal Simulation Centre using high-fidelity settings.
| Study group | Role | What they receive |
|---|---|---|
| Residents | Anesthesia residents from University of Montreal Anesthesia Department who were watching the video Receives: Behavioral: Video | |
| Attending Physicians | Attending physicians from University of Montreal Anesthesia Department who were watching the video Receives: Behavioral: Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between Time to First Fixation and Total View Duration of areas of interests.
The screen was equipped with TobiiEyeX®, an eye-tracking system that automatically aggregates gaze data. The display was divided in seven Areas of Interest (AOI). Data were collected using the Tobii Studio® program to obtain the total view duration (TVD) of the various AOIs.
Measured: The primary endpoint is collected during 15 minutes, throughout the viewing of the video by the participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start1 Jul 2016
- Primary completion1 Feb 2017
- Study completion1 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SimulationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Issam Tanoubi, Université de Montréal
- Investigators
- Issam Tanoubi, Dr, Study director, Université de MontrealKomi Sodoke, Msc, Principal investigator, Université de MontrealMathieu Tourangeau, Dr, Principal investigator, Université de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054272
- Sponsor's protocol ID
- Expertise-2016
- Status last verified
- May 2017
- First submitted
- 7 Feb 2017
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Perception Exploration Using Eye-tracking Technology in a Cannot Intubate/Cannot Oxygenate Simulation
- ClinicalTrials.gov ID
- NCT03054272
- Acronym / sponsor ID
- Expertise-2016
- Keywords
- High-fidelity simulation, Eye-tracking, Difficult intubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 15 Feb 2017 (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.
Using eye-tracking technology, the aim of this observational study is to compare the visual interests between attending physicians and residents watching a Cannot Intubate/Cannot Oxygenate (CICO) scripted and simulated scenario
Detailed description
Attending physicians and residents, from the department of Anesthesiology at the Université de Montréal were recruited on a voluntary basis. A 13-minute video based on a suggested CICO algorithm from the Difficult Airway Society to manage unanticipated difficult intubation in adults (3) was produced at the University of Montreal Simulation Centre using high-fidelity settings. The scenario was about a patient, with a cervical collar, in the post-anesthesia care unit. Throughout the video, the patient presents increasing respiratory distress worsening to respiratory failure. The anesthesiologist fails to ventilate, intubate and insert a laryngeal mask leading to a cricothyroidotomy. All participants were looking at a screen on which the scenario was broadcast. The screen was equipped with TobiiEyeX®, an eye-tracking system that automatically aggregates gaze data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Residents | – | Behavioral: VideoAnesthesia residents from University of Montreal Anesthesia Department who were watching the video |
| Attending Physicians | – | Behavioral: VideoAttending physicians from University of Montreal Anesthesia Department who were watching the video |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Residents and attending physicians from University of Montreal Anesthesia Department
Key inclusion criteria (1 listed)
- Residents and attending physicians from University of Montreal Anesthesia Department
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| VideoA 13-minute video based on a suggested CICO algorithm from the Difficult Airway Society that was produced at the University of Montreal Simulation Centre using high-fidelity settings. | Behavioural | Attending Physicians, Residents |
Primary outcome
Difference between Time to First Fixation and Total View Duration of areas of interests.
Time frame: The primary endpoint is collected during 15 minutes, throughout the viewing of the video by the participant
The screen was equipped with TobiiEyeX®, an eye-tracking system that automatically aggregates gaze data. The display was divided in seven Areas of Interest (AOI). Data were collected using the Tobii Studio® program to obtain the total view duration (TVD) of the various AOIs.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
- 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.
Issam Tanoubi, Dr study director
Université de Montreal
Komi Sodoke, Msc principal investigator
Université de Montreal
Mathieu Tourangeau, Dr principal investigator
Université de Montreal
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Simulation and Perception, run by Université de Montréal.
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 1 inclusion and 1 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 2 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference between Time to First Fixation and Total View Duration of areas of interests. (time frame: The primary endpoint is collected during 15 minutes, throughout the viewing of the video by the participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 May 2017.