Comparison of 4 Tactical Tourniquets Used in War Medicine

Not Applicable

Completed

• Conditions: Hemorrhage
• Interventions: Device: Tactical tourniquet set up; Diagnostic Test: Medical ultrasound; Other: Questionnaire

• Registration Number: NCT04870814
• Lead Sponsor: Direction Centrale du Service de Santé des Armées

Brief Summary

Bleeding remains the leading cause of death in combat, and the literature suggests that tourniquetable hemorrhage is the second leading cause of preventable death, behind non- tourniquetable hemorrhage.

Currently, most Western armed forces recommend the use of the tactical tourniquet in combat for the management of tourniquetable hemorrhage.

The SOFTT® tourniquet (Tactical Medical Solutions, Anderson) is the tactical tourniquet currently in use by the French armed forces. As the contract will soon come to an end, the question of its renewal arises.

The purpose of this study is to compare 4 commercially available tactical tourniquets in healthy volunteers.

The hypothesis of the research is that one of the 4 tourniquets compared is faster to set up than the others.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-29
• Study First Submitted QC: 2021-04-29
• Study First Posted: 2021-05-04
• Study Start: 2021-05-28
• Primary Completion: 2021-06-14
• Study Completion: 2021-06-14
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-06
• Last Update Posted: 2021-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Age ≥ 18 years;
• Student of the Military Health School of Lyon Bron (Ecoles Militaires de Santé de Lyon Bron; EMSLB);
• Periodic medical examination up to date with the mention "fitness for duty";
• Holder of the "Combat Rescue Level 1" training.

Exclusion Criteria

• Vascular pathology;
• Current progressive pathology of any kind;
• History of thrombo-embolic disease;
• Presence of cardiovascular risk factors (diabetes, hypertension, dyslipidemia, smoking > 1 cigarette/day, BMI > 25);
• Iliofemoral and axillary vascular abnormalities detected by systematic Doppler ultrasound;
• Presence of symptoms suggestive of COVID-19;
• Positive COVID-19 antigen test;
• In contact with a person diagnosed positive for COVID-19 within 15 days prior to inclusion;
• Pregnant or breastfeeding woman.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SAM XT® tactical tourniquet	Tactical tourniquet set up	The SAM XT® (SAM Medical Products®, Wilsonville) tactical tourniquet will be assessed.
SAM XT® tactical tourniquet	Medical ultrasound	The SAM XT® (SAM Medical Products®, Wilsonville) tactical tourniquet will be assessed.
SAM XT® tactical tourniquet	Questionnaire	The SAM XT® (SAM Medical Products®, Wilsonville) tactical tourniquet will be assessed.
RMT® 1.5 tactical tourniquet	Medical ultrasound	The RMT® 1.5 (m2®, Winooski) tactical tourniquet will be assessed.
SOFTT® Gen 4 tactical tourniquet	Tactical tourniquet set up	The SOFTT® Gen 4 (Tactical Medical Solutions, Anderson) tactical tourniquet will be assessed.
CAT® Gen 7 tactical tourniquet	Tactical tourniquet set up	The CAT® Gen 7 (C-A-T® Resources, Rock Hill) tactical tourniquet will be assessed.
CAT® Gen 7 tactical tourniquet	Medical ultrasound	The CAT® Gen 7 (C-A-T® Resources, Rock Hill) tactical tourniquet will be assessed.
RMT® 1.5 tactical tourniquet	Questionnaire	The RMT® 1.5 (m2®, Winooski) tactical tourniquet will be assessed.
CAT® Gen 7 tactical tourniquet	Questionnaire	The CAT® Gen 7 (C-A-T® Resources, Rock Hill) tactical tourniquet will be assessed.
SOFTT® Gen 4 tactical tourniquet	Questionnaire	The SOFTT® Gen 4 (Tactical Medical Solutions, Anderson) tactical tourniquet will be assessed.
SOFTT® Gen 4 tactical tourniquet	Medical ultrasound	The SOFTT® Gen 4 (Tactical Medical Solutions, Anderson) tactical tourniquet will be assessed.
RMT® 1.5 tactical tourniquet	Tactical tourniquet set up	The RMT® 1.5 (m2®, Winooski) tactical tourniquet will be assessed.

Primary Outcome Measures

Name	Time	Method
Time required to apply the tactical tourniquet.	Each day during 4 consecutive days	The tourniquet application time, in seconds, measured with a stopwatch. The stopwatch will be started when the fitter takes the tourniquet, pre-positioned in a tourniquet pouch on his bullet vest.; The stopwatch will be stopped as soon as at least one of the following conditions is verified; * the fitter judges the fitting to be effective; * the fitter cannot tighten any more (technical limit); * the tourniquet is too painful for the receiver.

Secondary Outcome Measures

Name	Time	Method
Rusticity of the tactical tourniquet	Each day during 4 consecutive days	The rusticity of the tactical tourniquet will be assessed via a questionnaire: "sufficiently rustic" or "not sufficiently rustic"
Pain experienced by the receiver during application of the tactical tourniquet	Each day during 4 consecutive days	Pain experienced by the receiver during application of the tactical tourniquet, measured by a scale ranging from 0 (no pain) to 10 (most unbearable pain).
Occlusion of the downstream arterial flow following after tactical tourniquet application	Each day during 4 consecutive days	The occlusion of the downstream arterial flow will be assessed by medical ultrasound after tactical tourniquet application
Ease of use of the tactical tourniquet	Each day during 4 consecutive days	The ease of use of the tactical tourniquet will be measured via a 5-point scale: "very easy", "easy", "intermediate", "hard" and "very hard".
Stability of the tactical tourniquet	Each day during 4 consecutive days	The stability of the tactical tourniquet will be assessed via a questionnaire, on a 5-point scale: "unstable", "not very stable", "moderately stable", "stable" or "extremely stable".

Trial Locations

Locations (1)

Hôpital d'Instruction des Armées Desgenettes; 🇫🇷 Lyon, France