Comparison of 4 Tactical Tourniquets Used in War Medicine

Direction Centrale du Service de Santé des Armées

Status: Completed

Conditions: Hemorrhage

Treatments: Device: Tactical tourniquet set up; Other: Questionnaire; Diagnostic Test: Medical ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT04870814

2021-A00049-32 (Other Identifier)

2020PPRC05

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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46 participants in 4 patient groups

SOFTT® Gen 4 tactical tourniquet

Active Comparator group

Description:

The SOFTT® Gen 4 (Tactical Medical Solutions, Anderson) tactical tourniquet will be assessed.

Treatment:

Other: Questionnaire

Diagnostic Test: Medical ultrasound

Device: Tactical tourniquet set up

CAT® Gen 7 tactical tourniquet

Active Comparator group

Description:

The CAT® Gen 7 (C-A-T® Resources, Rock Hill) tactical tourniquet will be assessed.

Treatment:

Other: Questionnaire

Diagnostic Test: Medical ultrasound

Device: Tactical tourniquet set up

SAM XT® tactical tourniquet

Active Comparator group

Description:

The SAM XT® (SAM Medical Products®, Wilsonville) tactical tourniquet will be assessed.

Treatment:

Other: Questionnaire

Diagnostic Test: Medical ultrasound

Device: Tactical tourniquet set up

RMT® 1.5 tactical tourniquet

Active Comparator group

Description:

The RMT® 1.5 (m2®, Winooski) tactical tourniquet will be assessed.

Treatment:

Other: Questionnaire

Diagnostic Test: Medical ultrasound

Device: Tactical tourniquet set up