Assessment of Automatic Tourniquets for Soldiers During Wartime

Trauma Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06123104
• Other study ID #: 1.1
• Status: Recruiting
• Phase: N/A
• Start date: October 27, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2024
• Source: Medical Corps, Israel Defense Force
• Contact: Tomer Erlich, MD
• Phone: +972-3-737-9506
• Email: tomer.erlich[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Trauma Injury

Intervention

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

Locations

Country	Name	City	State
Israel	Tel hashomer	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Medical Corps, Israel Defense Force

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.