Comparison of 4 Tactical Tourniquets Used in War Medicine

NCT04870814 | Completed

• 2 other identifiers: 2020PPRC052021-A00049-32
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhage

Keywords

Tactical tourniquet

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Occlusion of the downstream arterial flow following after tactical tourniquet application

  Each day during 4 consecutive days

• Ease of use of the tactical tourniquet

  Each day during 4 consecutive days

• Rusticity of the tactical tourniquet

  Each day during 4 consecutive days

• Stability of the tactical tourniquet

  Each day during 4 consecutive days

• Pain experienced by the receiver during application of the tactical tourniquet

  Each day during 4 consecutive days

Study Arms (4)

SOFTT® Gen 4 tactical tourniquet

ACTIVE COMPARATOR

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

Device: Tactical tourniquet set up; Diagnostic Test: Medical ultrasound; Other: Questionnaire

CAT® Gen 7 tactical tourniquet

ACTIVE COMPARATOR

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

Device: Tactical tourniquet set up; Diagnostic Test: Medical ultrasound; Other: Questionnaire

SAM XT® tactical tourniquet

ACTIVE COMPARATOR

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

Device: Tactical tourniquet set up; Diagnostic Test: Medical ultrasound; Other: Questionnaire

RMT® 1.5 tactical tourniquet

ACTIVE COMPARATOR

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

Device: Tactical tourniquet set up; Diagnostic Test: Medical ultrasound; Other: Questionnaire

Interventions

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.

CAT® Gen 7 tactical tourniquet; RMT® 1.5 tactical tourniquet; SAM XT® tactical tourniquet; SOFTT® Gen 4 tactical tourniquet

Medical ultrasound DIAGNOSTIC_TEST

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

CAT® Gen 7 tactical tourniquet; RMT® 1.5 tactical tourniquet; SAM XT® tactical tourniquet; SOFTT® Gen 4 tactical tourniquet

Questionnaire 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; RMT® 1.5 tactical tourniquet; SAM XT® tactical tourniquet; SOFTT® Gen 4 tactical tourniquet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Pregnant or breastfeeding woman.

Sponsors & Collaborators

• Direction Centrale du Service de Santé des Armées: lead

Study Sites (1)

Hôpital d'Instruction des Armées Desgenettes

Lyon, 69003, France

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

Ultrasonography; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 4, 2021
• Study Start: May 28, 2021
• Primary Completion: June 14, 2021
• Study Completion: June 14, 2021
• Last Updated: July 7, 2021

Record last verified: 2021-07

Locations

FR (1)