NCT05612828

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Nov 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Nov 2022Dec 2026

First Submitted

Initial submission to the registry

October 29, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

November 7, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 10, 2022

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

4.2 years

First QC Date

October 29, 2022

Last Update Submit

February 26, 2024

Conditions

Keywords

Combat Life SaverSimulation MedicineStress response

Outcome Measures

Primary Outcomes (6)

  • Duration time of the of use of tourniquet

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

    10 minutes

  • Correctness of treatment of severe bleeding

    Based on standardized forms (points on a standardised scale)

    10 minutes

  • Duration time of the of use of nasal airway

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

    10 minutes

  • Correctness of treatment of airway obstruction

    Based on standardized forms (points on a standardised scale)

    10 minutes

  • Duration time of the use of chest seal

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

    10 minutes

  • Correctness of treatment of open pneumothorax

    Based on standardized forms (points on a standardised scale)

    10 minutes

Secondary Outcomes (3)

  • Stress level 1

    1 hour

  • Stress level 2

    1 hour

  • Stress level 3

    1 hour

Study Arms (2)

Conventional training

EXPERIMENTAL

Combat Life Savers trained by conventional combat medicine approach.

Behavioral: Conventional versus simulation manikin training

Simulation manikin training

EXPERIMENTAL

Training based on principles of simulation medicine.

Behavioral: Conventional versus simulation manikin training

Interventions

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

Conventional trainingSimulation manikin training

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • active soldier during the Tactical Combat Casualty Care course

You may not qualify if:

  • not willing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Czech Technical University in Prague

Kladno, 27201, Czechia

Location

Related 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.

    PMID: 12583953BACKGROUND

MeSH Terms

Conditions

War-Related InjuriesFractures, Stress

Condition Hierarchy (Ancestors)

Wounds and InjuriesFractures, Bone

Study Officials

  • Karel Roubík, Ph.D.

    Czech Technical University in Prague

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: randomized control trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2022

First Posted

November 10, 2022

Study Start

November 7, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
upon final publication
Access Criteria
open access
More information

Locations