- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03054272
Visual Perception Exploration Using Eye-tracking Technology in a Cannot Intubate/Cannot Oxygenate Simulation
May 1, 2017 updated by: Issam Tanoubi, Université de Montréal
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
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
14
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Residents and attending physicians from University of Montreal Anesthesia Department
Description
Inclusion Criteria:
- Residents and attending physicians from University of Montreal Anesthesia Department
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Residents
Anesthesia residents from University of Montreal Anesthesia Department who were watching the video
|
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.
|
Attending Physicians
Attending physicians from University of Montreal Anesthesia Department who were watching the video
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
The primary endpoint is collected during 15 minutes, throughout the viewing of the video by the participant
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Komi Sodoke, Msc, Université de Montréal
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2016
Primary Completion (Actual)
February 1, 2017
Study Completion (Actual)
April 1, 2017
Study Registration Dates
First Submitted
February 7, 2017
First Submitted That Met QC Criteria
February 10, 2017
First Posted (Actual)
February 15, 2017
Study Record Updates
Last Update Posted (Actual)
May 2, 2017
Last Update Submitted That Met QC Criteria
May 1, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- Expertise-2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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