Comparison of 4 Tactical Tourniquets Used in War Medicine

Hemorrhage Clinical Trial

Official title:

Comparison of 4 Tactical Tourniquets Used in War Medicine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04870814
• Other study ID #: 2020PPRC05
• Secondary ID: 2021-A00049-32
• Status: Completed
• Phase: N/A
• Start date: May 28, 2021
• Est. completion date: June 14, 2021

Study information

• Verified date: July 2021
• Source: Direction Centrale du Service de Santé des Armées
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 14, 2021
• Est. primary completion date: June 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage

Intervention

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").

Locations

Country	Name	City	State
France	Hôpital d'Instruction des Armées Desgenettes	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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