Comparison of 4 Tactical Tourniquets Used in War Medicine

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of 4 Tactical Tourniquets Used in War Medicine

Conditions
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Hemorrhage

Intervention / Treatment
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* Device: Tactical tourniquet set up
* Diagnostic Test: Medical ultrasound
* Other: Questionnaire


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: All the participants will test the 4 tourniquets (1 tourniquet model = 1 arm) both as a fitter (the person who set up the tourniquet) and as a receiver (the person on whom the tourniquet is applied).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SOFTT® Gen 4 tactical tourniquet<br>The SOFTT® Gen 4 (Tactical Medical Solutions, Anderson) tactical tourniquet will be assessed. | Device: Tactical tourniquet set up<br>* The tactical tourniquet will be set up to the upper limb and the lower limb during a maximum of 2 minutes.<br>Diagnostic Test: Medical ultrasound<br>* The efficacy of tactical tourniquet set up will be assessed by medical ultrasound.<br>Other: Questionnaire<br>* The participants will have to fill a questionnaire assessing pain (for the receiver), ease of use, stability and rusticity (for the fitter).<br>|
| Active Comparator: CAT® Gen 7 tactical tourniquet<br>The CAT® Gen 7 (C-A-T® Resources, Rock Hill) tactical tourniquet will be assessed. | Device: Tactical tourniquet set up<br>* The tactical tourniquet will be set up to the upper limb and the lower limb during a maximum of 2 minutes.<br>Diagnostic Test: Medical ultrasound<br>* The efficacy of tactical tourniquet set up will be assessed by medical ultrasound.<br>Other: Questionnaire<br>* The participants will have to fill a questionnaire assessing pain (for the receiver), ease of use, stability and rusticity (for the fitter).<br>|
| Active Comparator: SAM XT® tactical tourniquet<br>The SAM XT® (SAM Medical Products®, Wilsonville) tactical tourniquet will be assessed. | Device: Tactical tourniquet set up<br>* The tactical tourniquet will be set up to the upper limb and the lower limb during a maximum of 2 minutes.<br>Diagnostic Test: Medical ultrasound<br>* The efficacy of tactical tourniquet set up will be assessed by medical ultrasound.<br>Other: Questionnaire<br>* The participants will have to fill a questionnaire assessing pain (for the receiver), ease of use, stability and rusticity (for the fitter).<br>|
| Active Comparator: RMT® 1.5 tactical tourniquet<br>The RMT® 1.5 (m2®, Winooski) tactical tourniquet will be assessed. | Device: Tactical tourniquet set up<br>* The tactical tourniquet will be set up to the upper limb and the lower limb during a maximum of 2 minutes.<br>Diagnostic Test: Medical ultrasound<br>* The efficacy of tactical tourniquet set up will be assessed by medical ultrasound.<br>Other: Questionnaire<br>* The participants will have to fill a questionnaire assessing pain (for the receiver), ease of use, stability and rusticity (for the fitter).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time required to apply the tactical tourniquet. | 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. | Each day during 4 consecutive days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occlusion of the downstream arterial flow following after tactical tourniquet application | The occlusion of the downstream arterial flow will be assessed by medical ultrasound after tactical tourniquet application | Each day during 4 consecutive days | 
| Ease of use of the tactical tourniquet | The ease of use of the tactical tourniquet will be measured via a 5-point scale: very easy, easy, intermediate, hard and very hard. | Each day during 4 consecutive days | 
| Rusticity of the tactical tourniquet | The rusticity of the tactical tourniquet will be assessed via a questionnaire: sufficiently rustic or not sufficiently rustic | Each day during 4 consecutive days | 
| Stability of the tactical tourniquet | 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. | Each day during 4 consecutive days | 
| Pain experienced by the receiver during application of the tactical tourniquet | 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). | Each day during 4 consecutive days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tactical tourniquet