- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05628519
Captain Sonar Impact on Trauma Patient Management (CAST2)
Trauma patient care requires collaboration and interaction with close relationship between many stakeholders from different professions (senior doctor, intern, nurse, nurse helpers, surgeons, etc).
This is a stressful situation where decision and action need to be quick, decisive and coordinate.
In this situation, quality of care and patient safety depends on a good interprofessional communication.
The acquisition of advanced communication skills, team management and leadership, stress management are essentials elements in the practice of Intensive and trauma care. However, advanced structured training or assessment of theses skills is lacking in medical education or Healthcare professionals training. The study therefore, aimed to develop a global and attractive training to help healthcare professionals to improve their skills.
Captain SonarTM is a naval battle game where two teams each composed of four participants clash. Each player has a well-defined role and it is imperative to communicate in a closed loop to advance in the game. This game also includes components similar to support for shock management: stress, speed of action, central communication and teamwork of four protagonists (Team Leader-Captain, intern-Second, nurse-Mechanic, Nurse help-Detector). It may improve team building, team leadership, interprofessional work, communication, stress management. The study hypothesis is that this board game would have an impact on the performance of professionals when facing a multiple trauma simulated patient. (differences in terms of technical and non-technical performance. Different use of closed loop communication, Different stress management, different efficiency and interprofessional collaboration with potentially a reduction in the timing of treatment being delivered in trauma room)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
All the teams of 4 participants and 1 medical Student previously trained will then benefit from a training session either exposed to captain sonar or into the control arm with monopoly.
High-fidelity and multiprofessional simulation session based on the incoming of a severe traumatized patient will be held. These sessions will take place on high-fidelity mannequins lent by the CLESS (Lyonnais Center for Health Simulation Education) in pavilion H of Édouard Herriot Hospital, within the Trauma Center (in situ).
The same scenario will be presented for all groups (exposed and controls) with the same objectives of realization and the same complexity. An audio-visual recording will take place during each session in order to allow the evaluation of the study criteria on technical and non technical skills between the participants a posteriori of the simulation session.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Rhone
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Lyon, Rhone, France, 69008
- Anesthesiology and Intensive care medicine, H Building, Hopital Edouard Herriot, Hospices Civils de Lyon
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Professional working at the Unit
Exclusion Criteria:
None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Captain Sonar
Participants will receive a training by a game session at Captain SonarTM of 60 min (including 15 min of presentation and prize in hand of the game) against a standardized investigator team
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Captain SonarTM is a naval battle game where two teams each composed of four participants clash.
Each player has a well-defined role and it is imperative to communicate in a closed loop to advance in the game.
This game also includes components similar to support for Trauma care: stress, speed of action, central communication and teamwork of four protagonists (Team Leader- Captain, intern-Second, nurse-Mechanic, Caregiver-Detector).
This short video describes the rules and the Game progress: https://vimeo.com/173614346.
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Placebo Comparator: Placebo Monopoly
The control group participants will benefit from a 60 min session to play a "Placebo" game: monopoly
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Participant will be invited to play to Monopoly during 60 min
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Technical skills
Time Frame: Measured during simulation session. Within 20 minutes of the simulation
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Total time of care in the trauma room, in seconds
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Measured during simulation session. Within 20 minutes of the simulation
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Non technical skills
Time Frame: Measured during simulation session. Within 20 minutes of the simulation
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use of closed loop communications: - count of the number of closed loops/minute |
Measured during simulation session. Within 20 minutes of the simulation
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Stress profile and stress management
Time Frame: immediately after simulation
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Visual Analog Scale of Stress, from 0 to 100 maximum
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immediately after simulation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Demographic data
Time Frame: At Baseline
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Demographic data (sex, age, previous experience as health care professional, experience in simulation, experience in gaming, experience in stress management)
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At Baseline
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Debriefing Evaluation
Time Frame: immediately After Debriefing
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Debriefing Assessment in Simulation in Healthcare (DASH) evaluated by team leader, nurse and facilitator, from 6 to 42 maximum
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immediately After Debriefing
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Influence of exposure on Performance, communication and stress management
Time Frame: immediately After simulation
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Visual analogic Scale, from 0 to 100 maximum
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immediately After simulation
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Technical skills grid
Time Frame: Measured during simulation session. Within 20 minutes of the simulation.
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Technical performance score (Grid out of 100 points); from 0 to 100 maximum
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Measured during simulation session. Within 20 minutes of the simulation.
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Technical skills key tasks
Time Frame: Measured during simulation session. Within 20 minutes of the simulation.
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Completion time for 5 key tasks (Hemocue result, blood pressure result, sample) in seconds Blood, realization of the FAST Ultrasound, Departure for OR/CT).
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Measured during simulation session. Within 20 minutes of the simulation.
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Technical skills self efficacy
Time Frame: Measured during simulation session. Within 20 minutes of the simulation.
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Self Efficacy estimation on Several cases, from 0 to 100 maximum Visual analog scale of support performance felt after the simulation session;
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Measured during simulation session. Within 20 minutes of the simulation.
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Non technical skills crew ressource 1
Time Frame: Measured during simulation session. Within 20 minutes of the simulation.
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Non technical skills score : from 0 to 54 maximum
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Measured during simulation session. Within 20 minutes of the simulation.
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Non technical skills crew ressource 2
Time Frame: Measured during simulation session. Within 20 minutes of the simulation.
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Non technical skills Score 2: from 1 to 5 maximum
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Measured during simulation session. Within 20 minutes of the simulation.
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Non technical skills communication anticipation
Time Frame: Measured during simulation session. Within 20 minutes of the simulation.
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Rate of anticipation of each participation (initiation of an act without prior request by the Team leader);
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Measured during simulation session. Within 20 minutes of the simulation.
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Non technical skills quality of team communication
Time Frame: immediately after simulation
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Visual Analog Scale quality of team communication, from 0 to 100 maximum.
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immediately after simulation
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Non technical skills confidence for team leader
Time Frame: immediately after simulation
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Visual Analog Scale of confidence in the team and the team leader , from 0 to 100 maximum.
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immediately after simulation
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Visual Analog Scale type of stress
Time Frame: immediately after the simulation session
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Visual Analog Scale of stress
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immediately after the simulation session
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Anxiety profile
Time Frame: immediately after the simulation session;
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Stait Trait Anxiety Inventory Trait, from 20 to 80 maximum.
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immediately after the simulation session;
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Stress profiles and stress management physiological measurement heart rate variability
Time Frame: During Simulation within the 20 minutes of simulation
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Physiological stress assessment of 2 of each team members will be performed throughout inclusion (during exposure and during simulation) and measured by non-invasive and continuous recording: - Heart and respiratory rates and heart rate variability (Hexoskin® t-shirt) |
During Simulation within the 20 minutes of simulation
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Stress profiles and stress management electrodermal activity
Time Frame: During Simulation within the 20 minutes of simulation
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Electrodermal activity, reflecting the stress and activation of individuals (Empatica E4 watch on the wrist non-dominant)
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During Simulation within the 20 minutes of simulation
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Collaborators and Investigators
Publications and helpful links
General Publications
- Neily J, Mills PD, Young-Xu Y, Carney BT, West P, Berger DH, Mazzia LM, Paull DE, Bagian JP. Association between implementation of a medical team training program and surgical mortality. JAMA. 2010 Oct 20;304(15):1693-700. doi: 10.1001/jama.2010.1506.
- Gawande AA, Zinner MJ, Studdert DM, Brennan TA. Analysis of errors reported by surgeons at three teaching hospitals. Surgery. 2003 Jun;133(6):614-21. doi: 10.1067/msy.2003.169.
- El-Shafy IA, Delgado J, Akerman M, Bullaro F, Christopherson NAM, Prince JM. Closed-Loop Communication Improves Task Completion in Pediatric Trauma Resuscitation. J Surg Educ. 2018 Jan-Feb;75(1):58-64. doi: 10.1016/j.jsurg.2017.06.025. Epub 2017 Aug 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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAST2 N°20-119
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
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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