Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2025-12-24 @ 2:15 PM
NCT ID:
NCT06640595
Brief Summary:
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.
Study:
NCT06640595
Study Brief:
Protocol Section:
NCT06640595