The Efficacy of Simulation Manikins in the Military Medics Training

February 26, 2024 updated by: Czech Technical University in Prague
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.

Study Overview

Status

Enrolling by invitation

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kladno, Czechia, 27201
        • Czech Technical University in Prague

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • active soldier during the Tactical Combat Casualty Care course

Exclusion Criteria:

  • not willing to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Conventional training
Combat Life Savers trained by conventional combat medicine approach.
Two approaches to training Combat Life Savers will be employed and performance of participants will be evaluated.
Experimental: Simulation manikin training
Training based on principles of simulation medicine.
Two approaches to training Combat Life Savers will be employed and performance of participants will be evaluated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration time of the of use of tourniquet
Time Frame: 10 minutes
Time to complete diagnostics and treatment of bleeding (in seconds)
10 minutes
Correctness of treatment of severe bleeding
Time Frame: 10 minutes
Based on standardized forms (points on a standardised scale)
10 minutes
Duration time of the of use of nasal airway
Time Frame: 10 minutes
Time to complete diagnostics and treatment of airway obstruction (in seconds)
10 minutes
Correctness of treatment of airway obstruction
Time Frame: 10 minutes
Based on standardized forms (points on a standardised scale)
10 minutes
Duration time of the use of chest seal
Time Frame: 10 minutes
Time to complete diagnostics and treatment of open pneumothorax (in seconds)
10 minutes
Correctness of treatment of open pneumothorax
Time Frame: 10 minutes
Based on standardized forms (points on a standardised scale)
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stress level 1
Time Frame: 1 hour
Level of stress response based on changes in blood pressure (in mm of mercury)
1 hour
Stress level 2
Time Frame: 1 hour
Level of stress response based on changes in heart rate (in beats per minute)
1 hour
Stress level 3
Time Frame: 1 hour
Level of stress response based on changes in cortisol level (in nmol/L)
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Karel Roubík, Ph.D., Czech Technical University in Prague

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

October 29, 2022

First Submitted That Met QC Criteria

November 9, 2022

First Posted (Actual)

November 10, 2022

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VentRes-2022-01-JP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

upon final publication

IPD Sharing Access Criteria

open access

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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