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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05612828
Other study ID # VentRes-2022-01-JP
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date November 7, 2022
Est. completion date December 31, 2026

Study information

Verified date February 2024
Source Czech Technical University in Prague
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 50
Est. completion date December 31, 2026
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - active soldier during the Tactical Combat Casualty Care course Exclusion Criteria: - not willing to participate

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Conventional versus simulation manikin training
Two approaches to training Combat Life Savers will be employed and performance of participants will be evaluated.

Locations

Country Name City State
Czechia Czech Technical University in Prague Kladno

Sponsors (2)

Lead Sponsor Collaborator
Czech Technical University in Prague Military University Hospital, Prague

Country where clinical trial is conducted

Czechia, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Duration time of the of use of tourniquet Time to complete diagnostics and treatment of bleeding (in seconds) 10 minutes
Primary Correctness of treatment of severe bleeding Based on standardized forms (points on a standardised scale) 10 minutes
Primary Duration time of the of use of nasal airway Time to complete diagnostics and treatment of airway obstruction (in seconds) 10 minutes
Primary Correctness of treatment of airway obstruction Based on standardized forms (points on a standardised scale) 10 minutes
Primary Duration time of the use of chest seal Time to complete diagnostics and treatment of open pneumothorax (in seconds) 10 minutes
Primary Correctness of treatment of open pneumothorax Based on standardized forms (points on a standardised scale) 10 minutes
Secondary Stress level 1 Level of stress response based on changes in blood pressure (in mm of mercury) 1 hour
Secondary Stress level 2 Level of stress response based on changes in heart rate (in beats per minute) 1 hour
Secondary Stress level 3 Level of stress response based on changes in cortisol level (in nmol/L) 1 hour
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