Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06640595
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-11
Brief Title:
Simulation Study on Advanced Medical Procedures Under Extreme Environments
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Simulation Study on Advanced Medical Procedures Under Extreme Environments
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SIMEX-MED
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 20C and once under cold temperature conditions -20C 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 ie orotracheal intubation with a videolaryngoscopy minithoracotomy and front of neck access under normal environmental conditions 20C compared to cold temperature -20C
Secondary outcomes
Secondary outcomes include the success rate for three different advanced medical procedures ie orotracheal intubation with a videolaryngoscopy minithoracotomy and front of neck access under normal environmental conditions 20C compared to cold temperature -20C Moreover the subjective difficulty of performing the procedures stress levels emotional regualtion and decision-making process will be assessed through a questionnaire
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 20C and once under cold temperature conditions -20C 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 ie orotracheal intubation with a videolaryngoscopy minithoracotomy and front of neck access under normal environmental conditions 20C compared to cold temperature -20C
Secondary outcomes
Secondary outcomes include the success rate for three different advanced medical procedures ie orotracheal intubation with a videolaryngoscopy minithoracotomy and front of neck access under normal environmental conditions 20C compared to cold temperature -20C Moreover the subjective difficulty of performing the procedures stress levels emotional regualtion and decision-making process will be assessed through a questionnaire
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None