Hemorrhage
Conditions
Keywords
Tactical tourniquet
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.
Interventions
DEVICETactical tourniquet set up
The tactical tourniquet will be set up to the upper limb and the lower limb during a maximum of 2 minutes.
DIAGNOSTIC_TESTMedical ultrasound
The efficacy of tactical tourniquet set up will be assessed by medical ultrasound.
OTHERQuestionnaire
The participants will have to fill a questionnaire assessing pain (for the receiver), ease of use, stability and rusticity (for the fitter).
Sponsors
Direction Centrale du Service de Santé des Armées
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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. |
| 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). |
Countries
France
Outcome results
None listed