Comparison of 4 Tactical Tourniquets Used in War Medicine

NCT ID: NCT04870814

Last Updated: 2021-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-28

Study Completion Date

2021-06-14

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.

Detailed Description

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Conditions

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Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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SOFTT® Gen 4 tactical tourniquet

The SOFTT® Gen 4 (Tactical Medical Solutions, Anderson) tactical tourniquet will be assessed.

Group Type ACTIVE_COMPARATOR

Tactical tourniquet set up

Intervention Type DEVICE

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

Medical ultrasound

Intervention Type DIAGNOSTIC_TEST

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

Questionnaire

Intervention Type OTHER

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

CAT® Gen 7 tactical tourniquet

The CAT® Gen 7 (C-A-T® Resources, Rock Hill) tactical tourniquet will be assessed.

Group Type ACTIVE_COMPARATOR

Tactical tourniquet set up

Intervention Type DEVICE

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

Medical ultrasound

Intervention Type DIAGNOSTIC_TEST

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

Questionnaire

Intervention Type OTHER

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

SAM XT® tactical tourniquet

The SAM XT® (SAM Medical Products®, Wilsonville) tactical tourniquet will be assessed.

Group Type ACTIVE_COMPARATOR

Tactical tourniquet set up

Intervention Type DEVICE

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

Medical ultrasound

Intervention Type DIAGNOSTIC_TEST

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

Questionnaire

Intervention Type OTHER

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

RMT® 1.5 tactical tourniquet

The RMT® 1.5 (m2®, Winooski) tactical tourniquet will be assessed.

Group Type ACTIVE_COMPARATOR

Tactical tourniquet set up

Intervention Type DEVICE

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

Medical ultrasound

Intervention Type DIAGNOSTIC_TEST

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

Questionnaire

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DEVICE

Medical ultrasound

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

Intervention Type DIAGNOSTIC_TEST

Questionnaire

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

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Direction Centrale du Service de Santé des Armées

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital d'Instruction des Armées Desgenettes

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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2021-A00049-32

Identifier Type: OTHER

Identifier Source: secondary_id

2020PPRC05

Identifier Type: -

Identifier Source: org_study_id

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