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Enrolling by invitationNCT05612828Updated Feb 28, 2024

The Efficacy of Simulation Manikins in the Military Medics Training

An interventional study of Conventional versus simulation manikin training in War-Related Injuries, sponsored by Czech Technical University in Prague. Enrolling by invitation at 1 site in Czechia. Per ClinicalTrials.gov, last updated 2024-02-28.

Sponsored by Czech Technical University in Prague · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Sex
All
01

Study 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.

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.

02

Conditions studied

  • War-Related Injuries

Keywords

  • Combat Life Saver
  • Simulation Medicine
  • Stress response
03

In context

Lead sponsor

Czech Technical University in Prague is the lead sponsor of 36 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • active soldier during the Tactical Combat Casualty Care course

Exclusion criteria

Exclusion Criteria:

  • not willing to participate
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Conventional training

    Combat Life Savers trained by conventional combat medicine approach.

    Behavioral: Conventional versus simulation manikin training

  • Experimental
    Simulation manikin training

    Training based on principles of simulation medicine.

    Behavioral: Conventional versus simulation manikin training

Interventions

  • BehavioralConventional versus simulation manikin training

    Two approaches to training Combat Life Savers will be employed and performance of participants will be evaluated.

06

What researchers measure

Primary outcomes

  1. Duration time of the of use of tourniquet

    Time to complete diagnostics and treatment of bleeding (in seconds)

    Time frame: 10 minutes

  2. Correctness of treatment of severe bleeding

    Based on standardized forms (points on a standardised scale)

    Time frame: 10 minutes

  3. Duration time of the of use of nasal airway

    Time to complete diagnostics and treatment of airway obstruction (in seconds)

    Time frame: 10 minutes

  4. Correctness of treatment of airway obstruction

    Based on standardized forms (points on a standardised scale)

    Time frame: 10 minutes

  5. Duration time of the use of chest seal

    Time to complete diagnostics and treatment of open pneumothorax (in seconds)

    Time frame: 10 minutes

  6. Correctness of treatment of open pneumothorax

    Based on standardized forms (points on a standardised scale)

    Time frame: 10 minutes

Secondary outcomes

  1. Stress level 1

    Level of stress response based on changes in blood pressure (in mm of mercury)

    Time frame: 1 hour

  2. Stress level 2

    Level of stress response based on changes in heart rate (in beats per minute)

    Time frame: 1 hour

  3. Stress level 3

    Level of stress response based on changes in cortisol level (in nmol/L)

    Time frame: 1 hour

07

Study locations

1 site
08

References and documents

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 ↗

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Informed consent form, Clinical study report

Time frame: upon final publication

Access criteria: open access

Data sharing details ↗ · ventilation.fbmi.cvut.cz

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2022 (actual). Primary completion is estimated for Dec 2026, 49 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 29, 2022
First posted
Nov 10, 2022
StartActual
Nov 7, 2022
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Feb 28, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05612828
Lead sponsor
Czech Technical University in Prague
Collaborators
Military University Hospital, Prague
Responsible party
Sponsor
First posted
Nov 10, 2022
Start date
Nov 7, 2022
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Feb 28, 2024

Study contacts

Karel Roubík, Ph.D.
study director · Czech Technical University in Prague

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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