Clinical trial NCT06640595: Simulation Study on Advanced Medical Procedures Under Extreme Environments
Official title: Simulation Study on Advanced Medical Procedures Under Extreme Environments
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cold Exposure
Keywords: Intubation
Front of neck access
Mini-Thoracotomy
Cold temperature
Lead sponsor: Institute of Mountain Emergency Medicine
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Members of the Medical Commission of the International Commission for Alpine Rescue (ICAR)

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Contraindications for exposure to cold temperatures

Primary outcomes:
measure: Difference in Time to perform the procedure
timeFrame: During the performance of the procedure
Secondary outcomes:
measure: Success rate
timeFrame: During the procedure
measure: Stress level
timeFrame: Immediately after the performance of the procedure
Other outcomes:
Locations:
city: Bolzano
country: Italy
facility: Eurac Research
Study officials:
affiliation: Institute of Mountain Emergency Medicine, Eurac research
name: Simon Rauch, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: