Assessment of Automatic Tourniquets for Soldiers During Wartime

Medical Corps, Israel Defense Force

Status: Enrolling

Conditions: Trauma Injury; Hemorrhage Wound

Treatments: Device: Occlusion of blood flow diagnosed by Point of Care UltraSound (POCUS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06123104

1.1

Details and patient eligibility

About

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.

Full 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).

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Automatic Tourniquet

Experimental group

Description:

Automatic pneumatic tourniquet

Treatment:

Device: Occlusion of blood flow diagnosed by Point of Care UltraSound (POCUS)

Combat Application Tourniquet (CAT)

Active Comparator group

Description:

Combat Application Tourniquet Generation 7

Treatment:

Device: Occlusion of blood flow diagnosed by Point of Care UltraSound (POCUS)