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Trauma InjuryCAST2NCT05628519

Captain Sonar Impact on Trauma Patient Management

A study testing Captain Sonar Exposition and Monopoly Exposition in people with Trauma Injury, run by Claude Bernard University at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Trauma Injury
What is being tested?
Captain Sonar Exposition and Monopoly Exposition
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteFrance
Study dates
1 Sep 2021to 1 Feb 2022
Phase
Interventional
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Professional working at the Unit

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

France1 site

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

    Lyon, Rhone, 69008

Other trials in France

About this study

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.

Read more

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)

Read the 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.

Conditions
Trauma Injury
Being tested
Captain Sonar Exposition, Monopoly Exposition
Keywords
Healthcare professionals, Technical Skills, Non Technical Skills, Crew ressource Management, Stress evaluation and management
Medical subject headings
Accidental Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Captain Sonar ExpositionBehavioural

    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.

  • Monopoly ExpositionBehavioural

    Participant will be invited to play to Monopoly during 60 min

Study groups in NCT05628519
Study groupRoleWhat they receive
Captain SonarExperimentalParticipants 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
Receives: Behavioral: Captain Sonar Exposition
Placebo MonopolyPlacebo comparatorThe control group participants will benefit from a 60 min session to play a "Placebo" game: monopoly
Receives: Behavioral: Monopoly Exposition

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Technical skills

    Total time of care in the trauma room, in seconds

    Measured: Measured during simulation session. Within 20 minutes of the simulation

  2. Non technical skills

    use of closed loop communications:

    • count of the number of closed loops/minute

    Measured: Measured during simulation session. Within 20 minutes of the simulation

  3. Stress profile and stress management

    Visual Analog Scale of Stress, from 0 to 100 maximum

    Measured: immediately after simulation

Secondary outcomes (15)

  1. Demographic data

    Demographic data (sex, age, previous experience as health care professional, experience in simulation, experience in gaming, experience in stress management)

    Measured: At Baseline

  2. Debriefing Evaluation

    Debriefing Assessment in Simulation in Healthcare (DASH) evaluated by team leader, nurse and facilitator, from 6 to 42 maximum

    Measured: immediately After Debriefing

  3. Influence of exposure on Performance, communication and stress management

    Visual analogic Scale, from 0 to 100 maximum

    Measured: immediately After simulation

  4. Technical skills grid

    Technical performance score (Grid out of 100 points); from 0 to 100 maximum

    Measured: Measured during simulation session. Within 20 minutes of the simulation.

  5. Technical skills key tasks

    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: Measured during simulation session. Within 20 minutes of the simulation.

  6. Technical skills self efficacy

    Self Efficacy estimation on Several cases, from 0 to 100 maximum Visual analog scale of support performance felt after the simulation session;

    Measured: Measured during simulation session. Within 20 minutes of the simulation.

  7. Non technical skills crew ressource 1

    Non technical skills score : from 0 to 54 maximum

    Measured: Measured during simulation session. Within 20 minutes of the simulation.

  8. Non technical skills crew ressource 2

    Non technical skills Score 2: from 1 to 5 maximum

    Measured: Measured during simulation session. Within 20 minutes of the simulation.

  9. Non technical skills communication anticipation

    Rate of anticipation of each participation (initiation of an act without prior request by the Team leader);

    Measured: Measured during simulation session. Within 20 minutes of the simulation.

  10. Non technical skills quality of team communication

    Visual Analog Scale quality of team communication, from 0 to 100 maximum.

    Measured: immediately after simulation

  11. Non technical skills confidence for team leader

    Visual Analog Scale of confidence in the team and the team leader , from 0 to 100 maximum.

    Measured: immediately after simulation

  12. Visual Analog Scale type of stress

    Visual Analog Scale of stress

    Measured: immediately after the simulation session

  13. Anxiety profile

    Stait Trait Anxiety Inventory Trait, from 20 to 80 maximum.

    Measured: immediately after the simulation session;

  14. Stress profiles and stress management physiological measurement heart rate variability

    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)

    Measured: During Simulation within the 20 minutes of simulation

  15. Stress profiles and stress management electrodermal activity

    Electrodermal activity, reflecting the stress and activation of individuals (Empatica E4 watch on the wrist non-dominant)

    Measured: During Simulation within the 20 minutes of simulation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2022
  2. Study start1 Sep 2021
  3. Primary completion1 Jan 2022
  4. Study completion1 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized control Trial, double blind
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05628519
Sponsor's protocol ID
CAST2 N°20-119
Acronym
CAST2
Status last verified
Nov 2022
First submitted
18 May 2022
Last updated
28 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 12796727

  • 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.

    PubMed 20959579

  • 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.

    PubMed 28780315

Questions about this trial

What is this clinical trial studying?

A study testing Captain Sonar Exposition and Monopoly Exposition in people with Trauma Injury, run by Claude Bernard University at 1 site in France.

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 28 Nov 2022. 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 France. 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. Some participants in this study may receive a placebo. 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?

Technical skills (time frame: Measured during simulation session. Within 20 minutes of the simulation). The study lists 3 primary outcomes in all. 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 NCT05628519, which also lists 3 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 28 Nov 2022.

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