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Eye Tracking and Simulated Postpartum Hemorrhage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04395963
Recruitment Status : Completed
First Posted : May 20, 2020
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
European e-Learning School in Obstetric Anesthesia

Brief Summary:

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.


Condition or disease Intervention/treatment
Simulation of Physical Illness Device: Tobii Pro Glasses 50 Hz wearable wireless eye tracker

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.

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Leader's Eye Tracking Patterns Changes During High Fidelity Simulation Scenarios of Postpartum Hemorrhage
Actual Study Start Date : November 20, 2019
Actual Primary Completion Date : February 28, 2020
Actual Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Tobii Pro Glasses 50 Hz wearable wireless eye tracker
    This system can measure eye movements using cameras integrated into the eyeglasses which record the corneal reflection of infrared lighting to track pupil position, mapping the subject's focus of attention on video recordings of the subject's field of vision (gaze).


Primary Outcome Measures :
  1. Eye-tracking and behavioral scores [ Time Frame: 15 minutes ]
    Correlation between eye-traking metrics, leader's behavior and team efficacy during the scenario


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
anesthesia trainee
Criteria

Inclusion Criteria:

  • anesthesia trainee

Exclusion Criteria:

  • severe vision defects

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04395963


Locations
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Italy
Eesoa Simulation Center
Roma, Italy, 00151
Sponsors and Collaborators
European e-Learning School in Obstetric Anesthesia
Investigators
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Study Director: Giorgio Capogna, MD European e-Learning School in Obstetric Anesthesia
Publications:
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Responsible Party: European e-Learning School in Obstetric Anesthesia
ClinicalTrials.gov Identifier: NCT04395963    
Other Study ID Numbers: EESOA7
First Posted: May 20, 2020    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Postpartum Hemorrhage
Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage