Assessment of Automatic Tourniquets for Soldiers During Wartime

NCT ID: NCT06123104

Last Updated: 2024-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-27

Study Completion Date

2024-12-30

Brief Summary

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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

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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).

Conditions

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Trauma Injury Hemorrhage Wound

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Automatic Tourniquet

Automatic pneumatic tourniquet

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

Tourniquets will be applied until peripheral blood flow occlusion is achieved. Total intervention time: up to 60 seconds

Combat Application Tourniquet (CAT)

Combat Application Tourniquet Generation 7

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

Tourniquets will be applied until peripheral blood flow occlusion is achieved. Total intervention time: up to 60 seconds

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical Corps, Israel Defense Force

OTHER

Sponsor Role lead

Responsible Party

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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)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tomer Erlich, MD

Role: PRINCIPAL_INVESTIGATOR

Head of Medical innovation and R&D

Locations

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Tel hashomer

Ramat Gan, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Tomer Erlich, MD

Role: CONTACT

+972-3-737-9506

Facility Contacts

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Tomer Erlich, MD

Role: primary

+972-3-737-9506

Other Identifiers

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1.1

Identifier Type: -

Identifier Source: org_study_id

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