Assessment of Automatic Tourniquets for Soldiers During Wartime

• Sponsor: Medical Corps, Israel Defense Force (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06123104
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 2.1
• Patients Per Site Per Month: 4.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Trauma Injury; Hemorrhage Wound	Device: Occlusion of blood flow	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: Assessment of Automatic Tourniquets for Soldiers During Wartime as Part of Accelerated Research and Development
• Actual Study Start Date: Oct 27, 2023
• Anticipated Primary Completion Date: Nov 30, 2023
• Anticipated Study Completion Date: Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Automatic Tourniquet Automatic pneumatic tourniquet	Device: Occlusion of blood flow; Tourniquets will be applied until peripheral blood flow occlusion is achieved. Total intervention time: up to 60 seconds
Active Comparator: CAT Combat Application Tourniquet Generation 7	Device: Occlusion of blood flow; Tourniquets will be applied until peripheral blood flow occlusion is achieved. Total intervention time: up to 60 seconds

Outcome Measures

Primary Outcome Measures

1. Time to distal limb arterial occlusion as assessed by Doppler [60 seconds]

Secondary Outcome Measures

1. 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

2. Usability of using automatic tourniquets [Ease of use will be assessed via questionnaire up to 5 minutes following the intervention.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tel hashomer	Ramat Gan		Israel

Sponsors and Collaborators

• Medical Corps, Israel Defense Force

Investigators

• Principal Investigator: Tomer Erlich, MD, Head of Medical innovation and R&D

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: TOMER ERLICH, 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), Medical Corps, Israel Defense Force
• ClinicalTrials.gov Identifier: NCT06123104
• Other Study ID Numbers: 1.1
• First Posted: Nov 8, 2023
• Last Update Posted: Nov 8, 2023
• Last Verified: Nov 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hemorrhage

Study Results

No Results Posted as of Nov 8, 2023