Assessment of Automatic Tourniquets for Soldiers During Wartime

Not Applicable

Recruiting

• Conditions: Hemorrhage Wound; Trauma Injury
• Interventions: Device: Occlusion of blood flow diagnosed by Point of Care UltraSound (POCUS)

• Registration Number: NCT06123104
• Lead Sponsor: Medical Corps, Israel Defense Force

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).

Study Timeline

• Study Start: 2023-10-27
• Study First Submitted: 2023-10-31
• Study First Submitted QC: 2023-11-06
• Study First Posted: 2023-11-08
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15
• Primary Completion: 2024-11-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Automatic Tourniquet	Occlusion of blood flow diagnosed by Point of Care UltraSound (POCUS)	Automatic pneumatic tourniquet
Combat Application Tourniquet (CAT)	Occlusion of blood flow diagnosed by Point of Care UltraSound (POCUS)	Combat Application Tourniquet Generation 7

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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"
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"

Trial Locations

Locations (1)

Tel hashomer; 🇮🇱 Ramat Gan, Israel