Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A00049-32 | Other Identifier | IDRCB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOFTT® Gen 4 tactical tourniquet | Active Comparator | The SOFTT® Gen 4 (Tactical Medical Solutions, Anderson) tactical tourniquet will be assessed. |
|
| CAT® Gen 7 tactical tourniquet | Active Comparator | The CAT® Gen 7 (C-A-T® Resources, Rock Hill) tactical tourniquet will be assessed. |
|
| SAM XT® tactical tourniquet | Active Comparator | The SAM XT® (SAM Medical Products®, Wilsonville) tactical tourniquet will be assessed. |
|
| RMT® 1.5 tactical tourniquet | Active Comparator | The RMT® 1.5 (m2®, Winooski) tactical tourniquet will be assessed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| 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
| Each day during 4 consecutive days |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital d'Instruction des Armées Desgenettes | Lyon | 69003 | France |
Not provided
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003625 | Data Collection |
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
| Medical ultrasound | Diagnostic Test | The efficacy of tactical tourniquet set up will be assessed by medical ultrasound. |
|
| Questionnaire | Other | The participants will have to fill a questionnaire assessing pain (for the "receiver"), ease of use, stability and rusticity (for the "fitter"). |
|
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 |
| D004812 |
| Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |