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Simulation Study on Advanced Medical Procedures Under Extreme Environments (SIMEX-MED)

I

Institute of Mountain Emergency Medicine

Status

Completed

Conditions

Cold Exposure

Study type

Observational

Funder types

Other

Identifiers

NCT06640595
SIMEX-MED

Details and patient eligibility

About

Background:

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.

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Members of the Medical Commission of the International Commission for Alpine Rescue (ICAR)

Exclusion criteria

  • Contraindications for exposure to cold temperatures

Trial design

36 participants in 2 patient groups

Cold Temperature
Description:
Performance of the procedure under cold temperature (-20°C)
Normal Temperature
Description:
Performance of the procedure under normal temperature (+20°C)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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