Simulation of Physical IllnessNCT04395963
Eye Tracking and Simulated Postpartum Hemorrhage
An observational study of Simulation of Physical Illness, run by European e-Learning School in Obstetric Anesthesia at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Simulation of Physical Illness
- What is being tested?
- Tobii Pro Glasses 50 Hz wearable wireless eye tracker
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 20 Nov 2019to 28 Feb 2020
- 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 25 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: anesthesia trainee
Who may be able to join
- anesthesia trainee
Who cannot join
- severe vision defects
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Simulation of Physical Illness
- Being tested
- Tobii Pro Glasses 50 Hz wearable wireless eye tracker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobii Pro Glasses 50 Hz wearable wireless eye trackerDevice
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
Eye-tracking and behavioral scores
Correlation between eye-traking metrics, leader's behavior and team efficacy during the scenario
Measured: 15 minutes
Secondary outcomes (1)
Eye-tracking and behavioral scores during the learning process
Correlation between eye-traking metrics, leader's behavior and team efficacy during the scenario and differences between the different scenarios played over the time
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start20 Nov 2019
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Simulation of Physical IllnessStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- European e-Learning School in Obstetric Anesthesia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giorgio Capogna, MD, Study director, European e-Learning School in Obstetric Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04395963
- Sponsor's protocol ID
- EESOA7
- Status last verified
- May 2020
- First submitted
- 15 May 2020
- Last updated
- 20 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 24881471Capogna 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.
PubMed 33541439
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leader's Eye Tracking Patterns Changes During High Fidelity Simulation Scenarios of Postpartum Hemorrhage
- ClinicalTrials.gov ID
- NCT04395963
- Acronym / sponsor ID
- EESOA7
- Conditions
- Simulation of Physical Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- European e-Learning School in Obstetric AnesthesiaUniversity, hospital or other
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 20 May 2020 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- anesthesia trainee
Key inclusion criteria (1 listed)
- anesthesia trainee
Key exclusion criteria (1 listed)
- severe vision defects
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 |
|---|---|---|
| Tobii Pro Glasses 50 Hz wearable wireless eye trackerThis 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). | Device | – |
Primary outcome
Eye-tracking and behavioral scores
Time frame: 15 minutes
Correlation between eye-traking metrics, leader's behavior and team efficacy during the scenario
1 secondary outcome
Eye-tracking and behavioral scores during the learning process
Time frame: 15 minutes
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 20 May 2020.
- Background: PubMed 24881471Tien 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.
- Derived from this study: PubMed 33541439Capogna 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.
- Individual participant dataSharing planned: Undecided
Related trials for Simulation of Physical Illness
Not yet recruiting
Moulage Technique in Child Abuse Recognition
Nursing Education, Simulation of Physical Illness
Active, not recruiting
Simulation Training in the Pediatric Tracheostomy and Home Ventilator Population
Tracheostomy Complication, Simulation of Physical Illness
Recruiting
The Holographic Standardized Patient
Medical Emergencies, Educational Problems
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.
Giorgio Capogna, MD study director
European e-Learning School in Obstetric Anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Simulation of Physical Illness, run by European e-Learning School in Obstetric Anesthesia at 1 site in Italy.
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 20 May 2020. 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 Italy. 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.
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?
Eye-tracking and behavioral scores (time frame: 15 minutes). 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 NCT04395963, which also lists 2 linked publications.
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 20 May 2020.