- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05612828
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
Conditions
Intervention / Treatment
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.
Collaborators
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.