The Efficacy of Simulation Manikins in the Military Medics Training
Primary Purpose
War-Related Injuries
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Conventional versus simulation manikin training
Sponsored by
About this trial
This is an interventional health services research trial for War-Related Injuries focused on measuring Combat Life Saver, Simulation Medicine, Stress response
Eligibility Criteria
Inclusion Criteria: active soldier during the Tactical Combat Casualty Care course Exclusion Criteria: not willing to participate
Sites / Locations
- Czech Technical University in Prague
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Conventional training
Simulation manikin training
Arm Description
Combat Life Savers trained by conventional combat medicine approach.
Training based on principles of simulation medicine.
Outcomes
Primary Outcome Measures
Duration time of the of use of tourniquet
Time to complete diagnostics and treatment of bleeding (in seconds)
Correctness of treatment of severe bleeding
Based on standardized forms (points on a standardised scale)
Duration time of the of use of nasal airway
Time to complete diagnostics and treatment of airway obstruction (in seconds)
Correctness of treatment of airway obstruction
Based on standardized forms (points on a standardised scale)
Duration time of the use of chest seal
Time to complete diagnostics and treatment of open pneumothorax (in seconds)
Correctness of treatment of open pneumothorax
Based on standardized forms (points on a standardised scale)
Secondary Outcome Measures
Stress level 1
Level of stress response based on changes in blood pressure (in mm of mercury)
Stress level 2
Level of stress response based on changes in heart rate (in beats per minute)
Stress level 3
Level of stress response based on changes in cortisol level (in nmol/L)
Full Information
NCT ID
NCT05612828
First Posted
October 29, 2022
Last Updated
December 10, 2022
Sponsor
Czech Technical University in Prague
Collaborators
Military University Hospital, Prague
1. Study Identification
Unique Protocol Identification Number
NCT05612828
Brief Title
The Efficacy of Simulation Manikins in the Military Medics Training
Official Title
The Efficacy of Simulation Manikins in the Military Medics Training
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 7, 2022 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Czech Technical University in Prague
Collaborators
Military University Hospital, Prague
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to verify the applicability of simulation manikin in combat training of military medics. The research will be conducted on healthy volunteers - medics of the Czech Armed Forces, as a part of the compulsory medical courses required for foreign military missions as a "Combat Life Saver". Comparison of the performance of two groups of course participants who were trained using the standard approach versus experiential learning using simulation manikins.
Detailed Description
With the development of modern hi-tech manikins and their growing popularity in the training of "civilian" medics, the possibilities of their application in the training of military medics are emerging. The aim of the study is to verify the applicability of simulation manikin in combat training of military medics. The research will be conducted on healthy volunteers - medics of the Czech Armed Forces, as a part of the compulsory medical courses required for foreign military missions as a "Combat Life Saver". Comparison of the performance of two groups of course participants who were trained using the standard approach versus experiential learning using simulation manikins. In addition to monitoring the particular professional performance of the trainees, changes in basic physiological functions, including the endocrinological response to stress conditions, will be evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
War-Related Injuries
Keywords
Combat Life Saver, Simulation Medicine, Stress response
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized control trial
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional training
Arm Type
Experimental
Arm Description
Combat Life Savers trained by conventional combat medicine approach.
Arm Title
Simulation manikin training
Arm Type
Experimental
Arm Description
Training based on principles of simulation medicine.
Intervention Type
Behavioral
Intervention Name(s)
Conventional versus simulation manikin training
Intervention Description
Two approaches to training Combat Life Savers will be employed and performance of participants will be evaluated.
Primary Outcome Measure Information:
Title
Duration time of the of use of tourniquet
Description
Time to complete diagnostics and treatment of bleeding (in seconds)
Time Frame
10 minutes
Title
Correctness of treatment of severe bleeding
Description
Based on standardized forms (points on a standardised scale)
Time Frame
10 minutes
Title
Duration time of the of use of nasal airway
Description
Time to complete diagnostics and treatment of airway obstruction (in seconds)
Time Frame
10 minutes
Title
Correctness of treatment of airway obstruction
Description
Based on standardized forms (points on a standardised scale)
Time Frame
10 minutes
Title
Duration time of the use of chest seal
Description
Time to complete diagnostics and treatment of open pneumothorax (in seconds)
Time Frame
10 minutes
Title
Correctness of treatment of open pneumothorax
Description
Based on standardized forms (points on a standardised scale)
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Stress level 1
Description
Level of stress response based on changes in blood pressure (in mm of mercury)
Time Frame
1 hour
Title
Stress level 2
Description
Level of stress response based on changes in heart rate (in beats per minute)
Time Frame
1 hour
Title
Stress level 3
Description
Level of stress response based on changes in cortisol level (in nmol/L)
Time Frame
1 hour
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
active soldier during the Tactical Combat Casualty Care course
Exclusion Criteria:
not willing to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karel Roubík, Ph.D.
Organizational Affiliation
Czech Technical University in Prague
Official's Role
Study Director
Facility Information:
Facility Name
Czech Technical University in Prague
City
Kladno
ZIP/Postal Code
27201
Country
Czechia
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
upon final publication
IPD Sharing Access Criteria
open access
IPD Sharing URL
https://ventilation.fbmi.cvut.cz/data/
Citations:
PubMed Identifier
12583953
Citation
McCarthy M. US military revamps combat medic training and care. Lancet. 2003 Feb 8;361(9356):494-5. doi: 10.1016/S0140-6736(03)12494-4. No abstract available.
Results Reference
background
Learn more about this trial
The Efficacy of Simulation Manikins in the Military Medics Training
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