- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04395963
Eye Tracking and Simulated Postpartum Hemorrhage
Leader's Eye Tracking Patterns Changes During High Fidelity Simulation Scenarios of Postpartum Hemorrhage
Eye tracking is the process of measuring an individual's eye movements in order to reflect their attentional behavior by using a device called an eye- tracker.
This study uses eye-tracking methodology to observe the gaze patterns of participants to a high fidelity simulation scenario of postpartum hemorrhage acting in the role of leader to evaluate the relationship between eye-tracking patterns and leadership and team behavioral and technical skills.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will include 5 groups of anesthesia trainees consisting of 5 participants each. Each group will practice a standardized high-fidelity scenario on postpartum hemorrhage (PPH) which will be repeated for four times. All the scenarios will be video recorded.
All groups will receive a technical briefing on the PPH guidelines before the scenario, and after having assigned to each participant a role (leader anesthesiologist, junior anesthesiologist, obstetrician, and midwife) they will practice a standardized 15 minutes scenario with a high fidelity manikin. A debriefing with an expert debriefer will be performed after each scenario.
The participant acting as the leader will practice the scenario while wearing a pair of eye-tracking glasses (Tobii Pro Glasses 50 Hz wearable wireless eye-tracker). All the eye-tracking video-recordings will be stored and analyzed by using a Tobii Pro Lab Software. Specific areas of interest (AOI), to define regions of a displayed stimulus, and to extract metrics specifically for those regions will be selected. Number and duration of fixations, visit counts and their duration for each area of interest and for each scenario will be examined. Eye-tracking metrics will be mapped as gaze plots and heat maps. Two independent observers will review the scenario video recordings and will assing a score to the leader and team behavioral and technical skills. These scores will be correlated to eye tracking metrics.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Roma, Italy, 00151
- Eesoa Simulation Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- anesthesia trainee
Exclusion Criteria:
- severe vision defects
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Eye-tracking and behavioral scores
Time Frame: 15 minutes
|
Correlation between eye-traking metrics, leader's behavior and team efficacy during the scenario
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15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Eye-tracking and behavioral scores during the learning process
Time Frame: 15 minutes
|
Correlation between eye-traking metrics, leader's behavior and team efficacy during the scenario and differences between the different scenarios played over the time
|
15 minutes
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Tien T, Pucher PH, Sodergren MH, Sriskandarajah K, Yang GZ, Darzi A. Eye tracking for skills assessment and training: a systematic review. J Surg Res. 2014 Sep;191(1):169-78. doi: 10.1016/j.jss.2014.04.032. Epub 2014 Apr 24.
- Capogna E, Capogna G, Raccis D, Salvi F, Velardo M, Del Vecchio A. Eye tracking metrics and leader's behavioral performance during a post-partum hemorrhage high-fidelity simulated scenario. Adv Simul (Lond). 2021 Feb 4;6(1):4. doi: 10.1186/s41077-021-00156-2.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EESOA7
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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