Captain Sonar Impact on Trauma Patient Management (CAST2)

November 24, 2022 updated by: Lilot Marc, Claude Bernard University

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

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

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Rhone
      • Lyon, Rhone, France, 69008
        • Anesthesiology and Intensive care medicine, H Building, Hopital Edouard Herriot, Hospices Civils de Lyon

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Professional working at the Unit

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

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
Placebo Comparator: Placebo Monopoly
The control group participants will benefit from a 60 min session to play a "Placebo" game: monopoly
Participant will be invited to play to Monopoly during 60 min

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical skills
Time Frame: Measured during simulation session. Within 20 minutes of the simulation
Total time of care in the trauma room, in seconds
Measured during simulation session. Within 20 minutes of the simulation
Non technical skills
Time Frame: Measured during simulation session. Within 20 minutes of the simulation

use of closed loop communications:

- count of the number of closed loops/minute

Measured during simulation session. Within 20 minutes of the simulation
Stress profile and stress management
Time Frame: immediately after simulation
Visual Analog Scale of Stress, from 0 to 100 maximum
immediately after simulation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic data
Time Frame: At Baseline
Demographic data (sex, age, previous experience as health care professional, experience in simulation, experience in gaming, experience in stress management)
At Baseline
Debriefing Evaluation
Time Frame: immediately After Debriefing
Debriefing Assessment in Simulation in Healthcare (DASH) evaluated by team leader, nurse and facilitator, from 6 to 42 maximum
immediately After Debriefing
Influence of exposure on Performance, communication and stress management
Time Frame: immediately After simulation
Visual analogic Scale, from 0 to 100 maximum
immediately After simulation
Technical skills grid
Time Frame: Measured during simulation session. Within 20 minutes of the simulation.
Technical performance score (Grid out of 100 points); from 0 to 100 maximum
Measured during simulation session. Within 20 minutes of the simulation.
Technical skills key tasks
Time Frame: Measured during simulation session. Within 20 minutes of the simulation.
Completion time for 5 key tasks (Hemocue result, blood pressure result, sample) in seconds Blood, realization of the FAST Ultrasound, Departure for OR/CT).
Measured during simulation session. Within 20 minutes of the simulation.
Technical skills self efficacy
Time Frame: Measured during simulation session. Within 20 minutes of the simulation.
Self Efficacy estimation on Several cases, from 0 to 100 maximum Visual analog scale of support performance felt after the simulation session;
Measured during simulation session. Within 20 minutes of the simulation.
Non technical skills crew ressource 1
Time Frame: Measured during simulation session. Within 20 minutes of the simulation.
Non technical skills score : from 0 to 54 maximum
Measured during simulation session. Within 20 minutes of the simulation.
Non technical skills crew ressource 2
Time Frame: Measured during simulation session. Within 20 minutes of the simulation.
Non technical skills Score 2: from 1 to 5 maximum
Measured during simulation session. Within 20 minutes of the simulation.
Non technical skills communication anticipation
Time Frame: Measured during simulation session. Within 20 minutes of the simulation.
Rate of anticipation of each participation (initiation of an act without prior request by the Team leader);
Measured during simulation session. Within 20 minutes of the simulation.
Non technical skills quality of team communication
Time Frame: immediately after simulation
Visual Analog Scale quality of team communication, from 0 to 100 maximum.
immediately after simulation
Non technical skills confidence for team leader
Time Frame: immediately after simulation
Visual Analog Scale of confidence in the team and the team leader , from 0 to 100 maximum.
immediately after simulation
Visual Analog Scale type of stress
Time Frame: immediately after the simulation session
Visual Analog Scale of stress
immediately after the simulation session
Anxiety profile
Time Frame: immediately after the simulation session;
Stait Trait Anxiety Inventory Trait, from 20 to 80 maximum.
immediately after the simulation session;
Stress profiles and stress management physiological measurement heart rate variability
Time Frame: During Simulation within the 20 minutes of simulation

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
Stress profiles and stress management electrodermal activity
Time Frame: During Simulation within the 20 minutes of simulation
Electrodermal activity, reflecting the stress and activation of individuals (Empatica E4 watch on the wrist non-dominant)
During Simulation within the 20 minutes of simulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

September 1, 2021

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

February 1, 2022

Study Registration Dates

First Submitted

May 18, 2022

First Submitted That Met QC Criteria

November 24, 2022

First Posted (Actual)

November 28, 2022

Study Record Updates

Last Update Posted (Actual)

November 28, 2022

Last Update Submitted That Met QC Criteria

November 24, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

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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