Simulation Study on Advanced Medical Procedures Under Extreme Environments
NCT ID: NCT06640595
Last Updated: 2024-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
36 participants
OBSERVATIONAL
2023-10-16
2023-10-17
Brief Summary
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In 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.
Methods:
On 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.
Outcomes:
Primary outcome:
The 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).
Secondary outcomes:
Secondary 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.
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Detailed Description
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Conditions
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Study Design
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CASE_CROSSOVER
PROSPECTIVE
Study Groups
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Cold Temperature
Performance of the procedure under cold temperature (-20°C)
No interventions assigned to this group
Normal Temperature
Performance of the procedure under normal temperature (+20°C)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Institute of Mountain Emergency Medicine
OTHER
Responsible Party
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Simon Rauch
Senior Researcher
Principal Investigators
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Simon Rauch, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Institute of Mountain Emergency Medicine, Eurac research
Locations
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Eurac Research
Bolzano, , Italy
Countries
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Other Identifiers
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SIMEX-MED
Identifier Type: -
Identifier Source: org_study_id
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