Assessment of Automatic Tourniquets for Soldiers During Wartime

Assessment of Automatic Tourniquets for Soldiers During Wartime as Part of Accelerated Research and Development

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.

Study Overview

• Status: Recruiting
• Conditions: Trauma Injury; Hemorrhage Wound
• Intervention / Treatment: Device: Occlusion of blood flow diagnosed by Point of Care UltraSound (POCUS)

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).

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tomer Erlich, MD; Phone Number: +972-3-737-9506; Email: tomer.erlich@gmail.com

Study Locations

• Israel
  • Ramat Gan, Israel
    • Recruiting
    • Tel Hashomer
    • Contact: Tomer Erlich, MD; Phone Number: +972-3-737-9506; Email: tomer.erlich@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Automatic Tourniquet; Automatic pneumatic tourniquet	Device: Occlusion 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
Active Comparator: Combat Application Tourniquet (CAT); Combat Application Tourniquet Generation 7	Device: Occlusion 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: Medical Corps, Israel Defense Force
• Investigators: Principal Investigator: Tomer Erlich, MD, Head of Medical innovation and R&D

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2023
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: November 6, 2023
• First Posted (Actual): November 8, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: 1.1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No