Hemorrhage Wound, Trauma Injury
Conditions
Brief summary
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: * Are AUTs effective in occlusion of blood flow * Are AUTs easy to use 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: 1. Limb blood flow 2. Ease of use 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.
Detailed description
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: * Are AUTs effective in occlusion of blood flow * Are AUTs easy to use Participants will be asked to place AUT and CAT on their upper limbs and lower limbs (8 applications overall).
Interventions
DEVICEOcclusion of blood flow diagnosed by Point of Care UltraSound (POCUS)
Tourniquets will be applied until peripheral blood flow occlusion is achieved. Total intervention time: up to 60 seconds
Sponsors
Medical Corps, Israel Defense Force
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
-Soldier in active service or active reserve service.
Exclusion criteria
* Muscle disorders * Peripheral nerve disorders * Skin diseases of the limbs * Limb surgery in the past * Rickets * Hypertension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to distal limb arterial occlusion as assessed by Doppler | 60 seconds | Time to distal limb arterial occlusion as assessed by Doppler is recorded |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of using automatic tourniquets | Will be assessed via questionnaire up to 5 minutes following the intervention. | 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 |
| Usability of using automatic tourniquets | Ease of use will be assessed via questionnaire up to 5 minutes following the intervention. | 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 |
Countries
Israel
Contacts
Primary ContactTomer Erlich, MD
Outcome results
None listed