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

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 Overview

• Status: Completed
• Conditions: Cold Exposure

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• Italy
  • Bolzano, Italy, 39100
    • Eurac Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Contraindications for exposure to cold temperatures

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cold Temperature; Performance of the procedure under cold temperature (-20°C)
Normal Temperature; Performance of the procedure under normal temperature (+20°C)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Time to perform the procedure	Difference in time required to perform 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).	During the performance of the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress level	Stress levels of the participants will be assessed through a questionnaire.	Immediately after the performance of the procedure
Success rate	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).	During the procedure

Collaborators and Investigators

• Sponsor: Institute of Mountain Emergency Medicine
• Investigators: Principal Investigator: Simon Rauch, MD, PhD, Institute of Mountain Emergency Medicine, EURAC Research

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2023
• Primary Completion (Actual): October 17, 2023
• Study Completion (Actual): October 17, 2023

Study Registration Dates

• First Submitted: October 11, 2024
• First Submitted That Met QC Criteria: October 11, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 12, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Intubation; Cold temperature; Front of neck access; Mini-Thoracotomy
• Other Study ID Numbers: SIMEX-MED

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No