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The goal of this clinical trial is to compare usability and performance of automatic tourniquets (AUT) and standard mechanical tourniquets (CAT) in healthy adults. The main questions it aims to answer are:
Participants will be asked to place AUT and CAT on their upper limbs and lower limbs (8 applications overall).
Following each application, the following parameters will be assessed:
Researchers will compare the results of the AUT and CAT to see if AUT is as effective as CAT in blood occlusion, and if AUT is easy to use as the CAT.
The goal of this clinical trial is to compare usability and performance of automatic tourniquets (AUT) and standard mechanical tourniquets (CAT) in healthy adults. The main questions it aims to answer are:
Participants will be asked to place AUT and CAT on their upper limbs and lower limbs (8 applications overall).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Automatic Tourniquet | Experimental | Automatic pneumatic tourniquet |
|
| Combat Application Tourniquet (CAT) | Active Comparator | Combat Application Tourniquet Generation 7 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Occlusion of blood flow diagnosed by Point of Care UltraSound (POCUS) | Device | Tourniquets will be applied until peripheral blood flow occlusion is achieved. Total intervention time: up to 60 seconds |
| Measure | Description | Time Frame |
|---|---|---|
| Time to distal limb arterial occlusion as assessed by Doppler | Time to distal limb arterial occlusion as assessed by Doppler is recorded | 60 seconds |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of using automatic tourniquets | Safety issues, specifically peripheral limb numbness will be assessed via questionnaire. Scale is from 0 to 5, 0 is "No numbness", 5 is "Severe numbness" | Will be assessed via questionnaire up to 5 minutes following the intervention. |
| Usability of using automatic tourniquets |
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Inclusion Criteria:
-Soldier in active service or active reserve service.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tomer Erlich, MD | Contact | +972-3-737-9506 | tomer.erlich@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Tomer Erlich, MD | Head of Medical innovation and R&D | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel hashomer | Recruiting | Ramat Gan | Israel |
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| ID | Term |
|---|---|
| D000081084 | Accidental Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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Usability of using automatic tourniquets will be assessed via questionnaire up to 5 minutes following the intervention. Scale for ease to secure the tourniquet is from 0 to 5, 0 is "Very difficult to secure", 5 is "Very easy to secure" |
| Ease of use will be assessed via questionnaire up to 5 minutes following the intervention. |