Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT03483727
Status:
COMPLETED
Last Update Posted:
2018-03-30
First Post:
2018-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of a Hand-held Digital Cognitive Aid in the Early Management of Simulated War Wounds.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'single'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'with or without the cognitive aid'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-23', 'studyFirstSubmitDate': '2018-03-23', 'studyFirstSubmitQcDate': '2018-03-23', 'lastUpdatePostDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Technical Performance as compared to a Reference Task List', 'timeFrame': 'Time 0-30 min', 'description': 'as compared to a Reference Task List'}], 'secondaryOutcomes': [{'measure': 'Non technical skills performance', 'timeFrame': 'Time 0-30 min', 'description': 'as measured by the Ottawa score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Combat Casualty Care']}, 'referencesModule': {'references': [{'pmid': '32091610', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nOur 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).\n\nThe present study exclusively deals with the management of combat casualties with the same digital cognitive aid adapted for MARCHE RYAN algorithm.', 'detailedDescription': '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.\n\nCombat 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).\n\nThe present study exclusively deals with the management of combat casualties with the digital cognitive aid MAX adapted for MARCHE RYAN algorithm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Soldiers\n* already trained in Combat Care level 2, under training for external operations.\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT03483727', 'acronym': 'SIMMAXMARCHE', 'briefTitle': 'Use of a Hand-held Digital Cognitive Aid in the Early Management of Simulated War Wounds.', 'organization': {'class': 'OTHER', 'fullName': 'Claude Bernard University'}, 'officialTitle': 'Use of a Hand-held Digital Cognitive Aid in the Early Management of Simulated War', 'orgStudyIdInfo': {'id': 'ClaudeBernardU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Digital cognitive aid', 'description': 'The digital cognitive aid is designed as a smartphone app.', 'interventionNames': ['Device: SIMMAXMARCHERYAN']}, {'type': 'EXPERIMENTAL', 'label': 'no digital cognitive aid', 'description': 'No cognitive aid in the hand of the leader during crises management.', 'interventionNames': ['Device: SIMMAXMARCHERYAN']}], 'interventions': [{'name': 'SIMMAXMARCHERYAN', 'type': 'DEVICE', 'description': 'Digital cognitive aid during the management of simulated combat wounded.', 'armGroupLabels': ['Digital cognitive aid', 'no digital cognitive aid']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Claude Bernard University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, mEng', 'investigatorFullName': 'CEJKA Jean-Christophe', 'investigatorAffiliation': 'Claude Bernard University'}}}}