Skip to main content
OpenTrials
Completed

NCT Number: NCT04870814

Comparison of 4 Tactical Tourniquets Used in War Medicine

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital d'Instruction des Armées Desgenettes

Lyon, 69003, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tactical tourniquet set up

Device

The tactical tourniquet will be set up to the upper limb and the lower limb during a maximum of 2 minutes.

Medical ultrasound

Diagnostic Test

The efficacy of tactical tourniquet set up will be assessed by medical ultrasound.

Questionnaire

Other

The participants will have to fill a questionnaire assessing pain (for the "receiver"), ease of use, stability and rusticity (for the "fitter").

Primary outcomes

  1. Time required to apply the tactical tourniquet.

    Time frame: 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 outcomes

  1. Occlusion of the downstream arterial flow following after tactical tourniquet application

    Time frame: Each day during 4 consecutive days

    The occlusion of the downstream arterial flow will be assessed by medical ultrasound after tactical tourniquet application

  2. Ease of use of the tactical tourniquet

    Time frame: 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".

  3. Rusticity of the tactical tourniquet

    Time frame: Each day during 4 consecutive days

    The rusticity of the tactical tourniquet will be assessed via a questionnaire: "sufficiently rustic" or "not sufficiently rustic"

  4. Stability of the tactical tourniquet

    Time frame: 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".

  5. Pain experienced by the receiver during application of the tactical tourniquet

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Direction Centrale du Service de Santé des Armées

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 4, 2021
Registry last updated
Jul 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.