Clinical trial NCT04870814: Comparison of 4 Tactical Tourniquets Used in War Medicine
Official title: Comparison of 4 Tactical Tourniquets Used in War Medicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemorrhage
Keywords: Tactical tourniquet
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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).
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Time required to apply the tactical tourniquet.
timeFrame: Each day during 4 consecutive days
Secondary outcomes:
measure: Occlusion of the downstream arterial flow following after tactical tourniquet application
timeFrame: Each day during 4 consecutive days
measure: Ease of use of the tactical tourniquet
timeFrame: Each day during 4 consecutive days
measure: Rusticity of the tactical tourniquet
timeFrame: Each day during 4 consecutive days
measure: Stability of the tactical tourniquet
timeFrame: Each day during 4 consecutive days
measure: Pain experienced by the receiver during application of the tactical tourniquet
timeFrame: Each day during 4 consecutive days
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital d'Instruction des Armées Desgenettes
Study officials:
References: