Simulation Study on Advanced Medical Procedures Under Extreme Environments

NCT06640595 | Completed

• 1 other identifier: SIMEX-MED
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Cold Exposure

Keywords

Intubation; Front of neck access; Mini-Thoracotomy; Cold temperature

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Success rate

  During the procedure

• Stress level

  Immediately after the performance of the procedure

Study Arms (2)

Cold Temperature

Performance of the procedure under cold temperature (-20°C)

Normal Temperature

Performance of the procedure under normal temperature (+20°C)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Contraindications for exposure to cold temperatures

Sponsors & Collaborators

• Institute of Mountain Emergency Medicine: lead

Study Sites (1)

Eurac Research

Bolzano, 39100, Italy

Location

Study Officials

• Simon Rauch, MD, PhD

  Institute of Mountain Emergency Medicine, Eurac research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 15, 2024
• Study Start: October 16, 2023
• Primary Completion: October 17, 2023
• Study Completion: October 17, 2023
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)