Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2026-01-02 @ 4:16 AM
Study NCT ID:
NCT06640595
Status:
COMPLETED
Last Update Posted:
2024-10-16
First Post:
2024-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Simulation Study on Advanced Medical Procedures Under Extreme Environments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-12', 'studyFirstSubmitDate': '2024-10-11', 'studyFirstSubmitQcDate': '2024-10-11', 'lastUpdatePostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in Time to perform the procedure', 'timeFrame': 'During the performance of the procedure', 'description': 'Difference in time required to perform three different advanced medical procedures, i.e. orotracheal intubation with a videolaryngoscopy, minithoracotomy, and front of neck access, under normal environmental conditions (+20°C) compared to cold temperature (-20°C).'}], 'secondaryOutcomes': [{'measure': 'Success rate', 'timeFrame': 'During the procedure', 'description': 'Success rate for three different advanced medical procedures, i.e. orotracheal intubation with a videolaryngoscopy, minithoracotomy, and front of neck access, under normal environmental conditions (+20°C) compared to cold temperature (-20°C).'}, {'measure': 'Stress level', 'timeFrame': 'Immediately after the performance of the procedure', 'description': 'Stress levels of the participants will be assessed through a questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intubation', 'Front of neck access', 'Mini-Thoracotomy', 'Cold temperature'], 'conditions': ['Cold Exposure']}, 'descriptionModule': {'briefSummary': 'Background:\n\nIn emergency situations in mountainous regions, medical professionals are often required to perform advanced medical procedures swiftly and efficiently. The choice of procedure and the environmental conditions can significantly impact the patient outcomes. This study seeks to evaluate the effectiveness of three advanced emergency medical procedures in a simulated scenario: orotracheal intubation with a videolaryngoscopy, minithoracotomy, and front of neck access, under both normal and cold temperature conditions.\n\nMethods:\n\nOn 16 and 17 October 2023, members of the Medical Commission of the International Commission for Alpine Rescue performed a simulation training in an extreme environmental simulation chamber (terraXcube) in Bolzano, Italy. During this, each participant will perform three advanced medical procedures, once under normal environmental conditions (+20°C) and once under cold temperature conditions (-20°C), in randomized order and with a crossover design. Specifically, the three advanced medical procedures consist of 1) simulation of a difficult orotracheal intubation on a dedicated mannikin with a videolaryngoscope; 2) front of neck access (FONA) with the scalpel-finger-bougie technique on a dedicated mannikin model; 3) minithoracotomy and chest tube placement on a dedicated mannikin model.\n\nOutcomes:\n\nPrimary outcome:\n\nThe primary outcome is the difference in time required for three different advanced medical procedures, i.e. orotracheal intubation with a videolaryngoscopy, minithoracotomy, and front of neck access, under normal environmental conditions (+20°C) compared to cold temperature (-20°C).\n\nSecondary outcomes:\n\nSecondary outcomes include the success rate for three different advanced medical procedures, i.e. orotracheal intubation with a videolaryngoscopy, minithoracotomy, and front of neck access, under normal environmental conditions (+20°C) compared to cold temperature (-20°C). Moreover, the subjective difficulty of performing the procedures, stress levels, emotional regualtion and decision-making process will be assessed through a questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Members of the Medical Commission of the International Commission for Alpine Rescue (ICAR)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Members of the Medical Commission of the International Commission for Alpine Rescue (ICAR)\n\nExclusion Criteria:\n\n* Contraindications for exposure to cold temperatures'}, 'identificationModule': {'nctId': 'NCT06640595', 'acronym': 'SIMEX-MED', 'briefTitle': 'Simulation Study on Advanced Medical Procedures Under Extreme Environments', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Mountain Emergency Medicine'}, 'officialTitle': 'Simulation Study on Advanced Medical Procedures Under Extreme Environments', 'orgStudyIdInfo': {'id': 'SIMEX-MED'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cold Temperature', 'description': 'Performance of the procedure under cold temperature (-20°C)'}, {'label': 'Normal Temperature', 'description': 'Performance of the procedure under normal temperature (+20°C)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '39100', 'city': 'Bolzano', 'country': 'Italy', 'facility': 'Eurac Research', 'geoPoint': {'lat': 46.49067, 'lon': 11.33982}}], 'overallOfficials': [{'name': 'Simon Rauch, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Mountain Emergency Medicine, Eurac research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Mountain Emergency Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Researcher', 'investigatorFullName': 'Simon Rauch', 'investigatorAffiliation': 'Institute of Mountain Emergency Medicine'}}}}