NCT03483727

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 30, 2018

Completed
Last Updated

March 30, 2018

Status Verified

March 1, 2018

Enrollment Period

5 months

First QC Date

March 23, 2018

Last Update Submit

March 23, 2018

Conditions

Combat Casualty Care

Outcome Measures

Primary Outcomes (1)

  • Technical Performance as compared to a Reference Task List

    as compared to a Reference Task List

    Time 0-30 min

Secondary Outcomes (1)

  • Non technical skills performance

    Time 0-30 min

Study Arms (2)

Digital cognitive aid

EXPERIMENTAL

The digital cognitive aid is designed as a smartphone app.

Device: SIMMAXMARCHERYAN

no digital cognitive aid

EXPERIMENTAL

No cognitive aid in the hand of the leader during crises management.

Device: SIMMAXMARCHERYAN

Interventions

SIMMAXMARCHERYANDEVICE

Digital cognitive aid during the management of simulated combat wounded.

Digital cognitive aidno digital cognitive aid

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Truchot M, Balanca B, Wey PF, Tazarourte K, Lecomte F, Le Goff A, Leigh-Smith S, Lehot JJ, Rimmele T, Cejka JC. Use of a Digital Cognitive Aid in the Early Management of Simulated War Wounds in a Combat Environment, a Randomized Trial. Mil Med. 2020 Aug 14;185(7-8):e1077-e1082. doi: 10.1093/milmed/usz482.

    PMID: 32091610DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
single
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: with or without the cognitive aid
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, mEng

Study Record Dates

First Submitted

March 23, 2018

First Posted

March 30, 2018

Study Start

January 1, 2017

Primary Completion

May 31, 2017

Study Completion

September 1, 2017

Last Updated

March 30, 2018

Record last verified: 2018-03