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.

Study Overview

• Status: Completed
• Conditions: Hemorrhage
• Intervention / Treatment: Device: Tactical tourniquet set up; Diagnostic test: Medical ultrasound; Other: Questionnaire

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69003
    • Hopital d'Instruction des Armées Desgenettes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Direction Centrale du Service de Santé des Armées

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2021
• Primary Completion (Actual): June 14, 2021
• Study Completion (Actual): June 14, 2021

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: April 29, 2021
• First Posted (Actual): May 4, 2021

Study Record Updates

• Last Update Posted (Actual): July 7, 2021
• Last Update Submitted That Met QC Criteria: July 6, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Tactical tourniquet
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: 2020PPRC05; 2021-A00049-32 (Other Identifier: IDRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No