Assessment of Automatic Tourniquets for Soldiers During Wartime

NCT06123104 | Recruiting

• 1 other identifier: 1.1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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:
• Limb blood flow
• Ease of use

Conditions

Trauma Injury; Hemorrhage Wound

Outcome Measures

Primary Outcomes (1)

• Time to distal limb arterial occlusion as assessed by Doppler

  Time to distal limb arterial occlusion as assessed by Doppler is recorded

  60 seconds

Secondary Outcomes (2)

• Safety of using automatic tourniquets

  Will be assessed via questionnaire up to 5 minutes following the intervention.

• Usability of using automatic tourniquets

  Ease of use will be assessed via questionnaire up to 5 minutes following the intervention.

Study Arms (2)

Automatic Tourniquet

EXPERIMENTAL

Automatic pneumatic tourniquet

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

Combat Application Tourniquet (CAT)

ACTIVE COMPARATOR

Combat Application Tourniquet Generation 7

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

Interventions

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

Automatic Tourniquet; Combat Application Tourniquet (CAT)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Soldier in active service or active reserve service.

You may not qualify if:

• Muscle disorders
• Peripheral nerve disorders
• Skin diseases of the limbs
• Limb surgery in the past
• Rickets
• Hypertension

Sponsors & Collaborators

• Medical Corps, Israel Defense Force: lead

Study Sites (1)

Tel hashomer

Ramat Gan, Israel

RECRUITING

MeSH Terms

Conditions

Accidental Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Tomer Erlich, MD

  Head of Medical innovation and R&D

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tomer Erlich, MD

CONTACT

+972-3-737-9506; tomer.erlich@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Innovation, R&D Directorate, IDF Medical Corps Head of Medical Research, Directorate of Defense R&D, Israeli Ministry of Defense (IMOD DDR&D)

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 8, 2023
• Study Start: October 27, 2023
• Primary Completion: November 30, 2024
• Study Completion: December 30, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

IL (1)