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Comparison of 4 Tactical Tourniquets Used in War Medicine

Primary Purpose

Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Tactical tourniquet set up
Medical ultrasound
Questionnaire
Sponsored by
Direction Centrale du Service de Santé des Armées
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hemorrhage focused on measuring Tactical tourniquet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hôpital d'Instruction des Armées Desgenettes

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

SOFTT® Gen 4 tactical tourniquet

CAT® Gen 7 tactical tourniquet

SAM XT® tactical tourniquet

RMT® 1.5 tactical tourniquet

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 29, 2021
Last Updated
July 6, 2021
Sponsor
Direction Centrale du Service de Santé des Armées
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1. Study Identification

Unique Protocol Identification Number
NCT04870814
Brief Title
Comparison of 4 Tactical Tourniquets Used in War Medicine
Official Title
Comparison of 4 Tactical Tourniquets Used in War Medicine
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 28, 2021 (Actual)
Primary Completion Date
June 14, 2021 (Actual)
Study Completion Date
June 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Direction Centrale du Service de Santé des Armées

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage
Keywords
Tactical tourniquet

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SOFTT® Gen 4 tactical tourniquet
Arm Type
Active Comparator
Arm Description
The SOFTT® Gen 4 (Tactical Medical Solutions, Anderson) tactical tourniquet will be assessed.
Arm Title
CAT® Gen 7 tactical tourniquet
Arm Type
Active Comparator
Arm Description
The CAT® Gen 7 (C-A-T® Resources, Rock Hill) tactical tourniquet will be assessed.
Arm Title
SAM XT® tactical tourniquet
Arm Type
Active Comparator
Arm Description
The SAM XT® (SAM Medical Products®, Wilsonville) tactical tourniquet will be assessed.
Arm Title
RMT® 1.5 tactical tourniquet
Arm Type
Active Comparator
Arm Description
The RMT® 1.5 (m2®, Winooski) tactical tourniquet will be assessed.
Intervention Type
Device
Intervention Name(s)
Tactical tourniquet set up
Intervention Description
The tactical tourniquet will be set up to the upper limb and the lower limb during a maximum of 2 minutes.
Intervention Type
Diagnostic Test
Intervention Name(s)
Medical ultrasound
Intervention Description
The efficacy of tactical tourniquet set up will be assessed by medical ultrasound.
Intervention Type
Other
Intervention Name(s)
Questionnaire
Intervention Description
The participants will have to fill a questionnaire assessing pain (for the "receiver"), ease of use, stability and rusticity (for the "fitter").
Primary Outcome Measure Information:
Title
Time required to apply the tactical tourniquet.
Description
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.
Time Frame
Each day during 4 consecutive days
Secondary Outcome Measure Information:
Title
Occlusion of the downstream arterial flow following after tactical tourniquet application
Description
The occlusion of the downstream arterial flow will be assessed by medical ultrasound after tactical tourniquet application
Time Frame
Each day during 4 consecutive days
Title
Ease of use of the tactical tourniquet
Description
The ease of use of the tactical tourniquet will be measured via a 5-point scale: "very easy", "easy", "intermediate", "hard" and "very hard".
Time Frame
Each day during 4 consecutive days
Title
Rusticity of the tactical tourniquet
Description
The rusticity of the tactical tourniquet will be assessed via a questionnaire: "sufficiently rustic" or "not sufficiently rustic"
Time Frame
Each day during 4 consecutive days
Title
Stability of the tactical tourniquet
Description
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".
Time Frame
Each day during 4 consecutive days
Title
Pain experienced by the receiver during application of the tactical tourniquet
Description
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).
Time Frame
Each day during 4 consecutive days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Hôpital d'Instruction des Armées Desgenettes
City
Lyon
ZIP/Postal Code
69003
Country
France

12. IPD Sharing Statement

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Comparison of 4 Tactical Tourniquets Used in War Medicine

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