Trauma InjuryNCT06123104
Assessment of Automatic Tourniquets for Soldiers During Wartime
A study testing Occlusion of blood flow diagnosed by Point of Care UltraSound (POCUS) in people with Trauma Injury and Hemorrhage Wound, run by Medical Corps, Israel Defense Force at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Trauma Injury, Hemorrhage Wound
- What is being tested?
- Occlusion of blood flow diagnosed by Point of Care UltraSound (POCUS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- 27 Oct 2023to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -Soldier in active service or active reserve service.
Who cannot join
- Muscle disorders
- Peripheral nerve disorders
- Skin diseases of the limbs
- Limb surgery in the past
- Rickets
- Hypertension
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Tel hashomer
Ramat Gan
Tomer Erlich, MD, +972-3-737-9506, tomer.erlich@gmail.com
About this study
Official title: 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:
- Limb blood flow
- 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.
Read the 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).
- Conditions
- Trauma Injury, Hemorrhage Wound
- Being tested
- Occlusion of blood flow diagnosed by Point of Care UltraSound (POCUS)
- Medical subject headings
- Accidental Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occlusion of blood flow diagnosed by Point of Care UltraSound (POCUS)Device
Tourniquets will be applied until peripheral blood flow occlusion is achieved. Total intervention time: up to 60 seconds
| Study group | Role | What they receive |
|---|---|---|
| Automatic Tourniquet | Experimental | Automatic pneumatic tourniquet Receives: Device: Occlusion of blood flow diagnosed by Point of Care UltraSound (POCUS) |
| Combat Application Tourniquet (CAT) | Active comparator | Combat Application Tourniquet Generation 7 Receives: Device: Occlusion of blood flow diagnosed by Point of Care UltraSound (POCUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to distal limb arterial occlusion as assessed by Doppler
Time to distal limb arterial occlusion as assessed by Doppler is recorded
Measured: 60 seconds
Secondary outcomes (2)
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"
Measured: 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"
Measured: Ease of use will be assessed via questionnaire up to 5 minutes following the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start27 Oct 2023
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Corps, Israel Defense Force
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TOMER ERLICH, Medical Corps, Israel Defense Force
- Investigators
- Tomer Erlich, MD, Principal investigator, Head of Medical innovation and R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123104
- Sponsor's protocol ID
- 1.1
- Status last verified
- Mar 2024
- First submitted
- 31 Oct 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Automatic Tourniquets for Soldiers During Wartime as Part of Accelerated Research and Development
- ClinicalTrials.gov ID
- NCT06123104
- Acronym / sponsor ID
- 1.1
- Conditions
- Trauma Injury, Hemorrhage Wound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Medical Corps, Israel Defense ForceUniversity, hospital or other
- Study start
- 27 Oct 2023 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Limb blood flow
- 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 design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Automatic Tourniquet | Experimental | Device: Occlusion of blood flow diagnosed by Point of Care UltraSound (POCUS)Automatic pneumatic tourniquet |
| Combat Application Tourniquet (CAT) | Active comparator | Device: Occlusion of blood flow diagnosed by Point of Care UltraSound (POCUS)Combat Application Tourniquet Generation 7 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -Soldier in active service or active reserve service.
Key exclusion criteria (6 listed)
- Muscle disorders
- Peripheral nerve disorders
- Skin diseases of the limbs
- Limb surgery in the past
- Rickets
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Automatic Tourniquet, Combat Application Tourniquet (CAT) |
Primary outcome
Time to distal limb arterial occlusion as assessed by Doppler
Time frame: 60 seconds
Time to distal limb arterial occlusion as assessed by Doppler is recorded
2 secondary outcomes
Safety of using automatic tourniquets
Time frame: Will be assessed via questionnaire up to 5 minutes following the intervention.
Usability of using automatic tourniquets
Time frame: Ease of use will be assessed via questionnaire up to 5 minutes following the intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomer Erlich, MD principal investigator
Head of Medical innovation and R&D
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occlusion of blood flow diagnosed by Point of Care UltraSound (POCUS) in people with Trauma Injury and Hemorrhage Wound, run by Medical Corps, Israel Defense Force at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tomer Erlich, MD (+972-3-737-9506, tomer.erlich@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to distal limb arterial occlusion as assessed by Doppler (time frame: 60 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.