NCT06640595: SIMEX-MED

Simulation Study on Advanced Medical Procedures Under Extreme Environments

Completed Last updated 16 October 2024

What this trial tests

trial in Cold Exposure in 36 participants. Completed in 17 October 2023.

Timeline

16 October 2023

Primary endpoint
17 October 2023

17 October 2023

Quick facts

Lead sponsor	Institute of Mountain Emergency Medicine
Status	Completed
Study type	OBSERVATIONAL
Enrollment	36
Start date	16 October 2023
Primary completion	17 October 2023
Estimated completion	17 October 2023
Sites	1 location across Italy

Conditions studied

• Cold Exposure — all drugs for Cold Exposure →

Sponsor

Institute of Mountain Emergency Medicine

Who can join

18 and older, any sex, with Cold Exposure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of cold environments on technical performance and perceived workload and stress during advanced medical procedures: a randomized controlled simulation study.
   Roveri G, Gamberini L, Borotto E, Eisendle F, et al · · 2025 · cited 2× · PMID 40598316 · DOI 10.1186/s13049-025-01373-8