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Use of a Hand-held Digital Cognitive Aid in the Early Management of Simulated War Wounds. (SIMMAXMARCHE)

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ClinicalTrials.gov Identifier: NCT03483727
Recruitment Status : Completed
First Posted : March 30, 2018
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
CEJKA Jean-Christophe, Claude Bernard University

Study Description
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Brief Summary:

Combat casualty care has proven to increase survival rate in military conflict by treating without delay the quickest-to-kill wounds. The French militaries are trained to the MARCHE RYAN acronym, an algorithm designed to help every soldiers provide simple treatment in order to bring the patient to the surgeon alive.

Our first study (MAX, Lelaidier et al, BJA 2017) clearly showed that the use of a digital cognitive aid in the hand of the leader significantly improves the management of anaesthesia & intensive care emergencies (malignant hyperthermia, anaphylactic shock, acute toxicity of local anaesthetics, severe and symptomatic hyperkalaemia).

The present study exclusively deals with the management of combat casualties with the same digital cognitive aid adapted for MARCHE RYAN algorithm.


Condition or disease Intervention/treatment Phase
Combat Casualty Care Device: SIMMAXMARCHERYAN Not Applicable

Detailed Description:

In a first study (MAX, BJA 2017, Lelaidier et al) the investigators designed a digital cognitive aid (MAX for Medical Assistant eXpert) under the form of a smartphone application including 5 scenarios of anaesthesia and intensive care crises (malignant hyperthermia, anaphylactic shock, acute toxicity of local anaesthetics, severe and symptomatic hyperkalaemia, ventricular fibrillation), designed to be used in the hand of the leader managing the situations. Technical and non-technical skills were improved in 4 out of 5 scenarios.

Combat casualties are dealt with a stereotyped management in the French army, and all soldiers learn the algorithm (acronym) designed for this purpose, the MARCHE RYAN. Situations requiring the use of the MARCHE RYAN are extremely stressful (on the battlefield, performed by non-medical personal, often on a comrade).

The present study exclusively deals with the management of combat casualties with the digital cognitive aid MAX adapted for MARCHE RYAN algorithm.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: with or without the cognitive aid
Masking: Single (Participant)
Masking Description: single
Primary Purpose: Treatment
Official Title: Use of a Hand-held Digital Cognitive Aid in the Early Management of Simulated War
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : May 31, 2017
Actual Study Completion Date : September 1, 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: Digital cognitive aid
The digital cognitive aid is designed as a smartphone app.
 Device: SIMMAXMARCHERYAN
Digital cognitive aid during the management of simulated combat wounded.
Experimental: no digital cognitive aid
No cognitive aid in the hand of the leader during crises management.
 Device: SIMMAXMARCHERYAN
Digital cognitive aid during the management of simulated combat wounded.


Outcome Measures
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Primary Outcome Measures :
  1. Technical Performance as compared to a Reference Task List [ Time Frame: Time 0-30 min ]
    as compared to a Reference Task List


Secondary Outcome Measures :
  1. Non technical skills performance [ Time Frame: Time 0-30 min ]
    as measured by the Ottawa score


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Soldiers
  • already trained in Combat Care level 2, under training for external operations.

Exclusion Criteria:

  • none
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: CEJKA Jean-Christophe, MD, PhD, mEng, Claude Bernard University
ClinicalTrials.gov Identifier: NCT03483727    
Other Study ID Numbers: ClaudeBernardU
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018
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