War-Related InjuriesNCT05612828
The Efficacy of Simulation Manikins in the Military Medics Training
A study testing Conventional versus simulation manikin training in people with War-Related Injuries, run by Czech Technical University in Prague at 1 site in Czechia.
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". Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- War-Related Injuries
- What is being tested?
- Conventional versus simulation manikin training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCzechia
- Study dates
- 7 Nov 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- active soldier during the Tactical Combat Casualty Care course
Who cannot join
- not willing to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- War-Related Injuries
- Being tested
- Conventional versus simulation manikin training
- Keywords
- Combat Life Saver, Simulation Medicine, Stress response
- Medical subject headings
- War-Related Injuries, Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional versus simulation manikin trainingBehavioural
Two approaches to training Combat Life Savers will be employed and performance of participants will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Conventional training | Experimental | Combat Life Savers trained by conventional combat medicine approach. Receives: Behavioral: Conventional versus simulation manikin training |
| Simulation manikin training | Experimental | Training based on principles of simulation medicine. Receives: Behavioral: Conventional versus simulation manikin training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration time of the of use of tourniquet
Time to complete diagnostics and treatment of bleeding (in seconds)
Measured: 10 minutes
Correctness of treatment of severe bleeding
Based on standardized forms (points on a standardised scale)
Measured: 10 minutes
Duration time of the of use of nasal airway
Time to complete diagnostics and treatment of airway obstruction (in seconds)
Measured: 10 minutes
Correctness of treatment of airway obstruction
Based on standardized forms (points on a standardised scale)
Measured: 10 minutes
Duration time of the use of chest seal
Time to complete diagnostics and treatment of open pneumothorax (in seconds)
Measured: 10 minutes
Correctness of treatment of open pneumothorax
Based on standardized forms (points on a standardised scale)
Measured: 10 minutes
Secondary outcomes (3)
Stress level 1
Level of stress response based on changes in blood pressure (in mm of mercury)
Measured: 1 hour
Stress level 2
Level of stress response based on changes in heart rate (in beats per minute)
Measured: 1 hour
Stress level 3
Level of stress response based on changes in cortisol level (in nmol/L)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start7 Nov 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for War-Related InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized control trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Czech Technical University in Prague
- Sponsor type
- University, hospital or other
- Collaborators
- Military University Hospital, Prague
- Responsible party
- Sponsor
- Investigators
- Karel Roubík, Ph.D., Study director, Czech Technical University in Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612828
- Sponsor's protocol ID
- VentRes-2022-01-JP
- Status last verified
- Feb 2024
- First submitted
- 29 Oct 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 12583953
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Simulation Manikins in the Military Medics Training
- ClinicalTrials.gov ID
- NCT05612828
- Acronym / sponsor ID
- VentRes-2022-01-JP
- Conditions
- War-Related Injuries
- Keywords
- Combat Life Saver, Simulation Medicine, Stress response
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Czech Technical University in PragueUniversity, hospital or other
- Collaborators
- Military University Hospital, Prague
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Conventional training | Experimental | Behavioral: Conventional versus simulation manikin trainingCombat Life Savers trained by conventional combat medicine approach. |
| Simulation manikin training | Experimental | Behavioral: Conventional versus simulation manikin trainingTraining based on principles of simulation medicine. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- active soldier during the Tactical Combat Casualty Care course
Key exclusion criteria (1 listed)
- not willing to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional versus simulation manikin trainingTwo approaches to training Combat Life Savers will be employed and performance of participants will be evaluated. | Behavioural | Conventional training, Simulation manikin training |
Primary outcome
Duration time of the of use of tourniquet
Time frame: 10 minutes
Time to complete diagnostics and treatment of bleeding (in seconds)
Correctness of treatment of severe bleeding
Time frame: 10 minutes
Based on standardized forms (points on a standardised scale)
Duration time of the of use of nasal airway
Time frame: 10 minutes
Time to complete diagnostics and treatment of airway obstruction (in seconds)
Correctness of treatment of airway obstruction
Time frame: 10 minutes
Based on standardized forms (points on a standardised scale)
Duration time of the use of chest seal
Time frame: 10 minutes
Time to complete diagnostics and treatment of open pneumothorax (in seconds)
Correctness of treatment of open pneumothorax
Time frame: 10 minutes
Based on standardized forms (points on a standardised scale)
3 secondary outcomes
Stress level 1
Time frame: 1 hour
Stress level 2
Time frame: 1 hour
Stress level 3
Time frame: 1 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Background: PubMed 12583953McCarthy 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karel Roubík, Ph.D. study director
Czech Technical University in Prague
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional versus simulation manikin training in people with War-Related Injuries, run by Czech Technical University in Prague at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration time of the of use of tourniquet (time frame: 10 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05612828, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.