Junctional HemorrhageNCT06007209
Blind Vs US Guided Manual Pressure Points
A study testing Manual Pressure Point in people with Junctional Hemorrhage and Extremity Hemorrhage, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
the goal of this clinical trial is to compare the effectiveness of manual pressure points (femoral and supra-clavicular) for hemorrhage control by military medics using either the traditional blind manual technique or an ultrasound guided technique in healthy human volunteers. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Junctional Hemorrhage, Extremity Hemorrhage
- What is being tested?
- Manual Pressure Point
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Aug 2023to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age > 18 years.
- Combat pararescue medics who have completed their medics training course.
- Informed consent.
Who cannot join
- Any medical condition that causes or may cause discomfort during the experiment, including specifically conditions involving the groin, shoulder and neck.
- Any known vascular disease, including any known familial hypercoagulability disorder.
- Any known peripheral neuropathy.
- All of the above will be based on subjects' self-reporting. Subjects will be encouraged to consult with the unit's physician who will not be part of the study team but will be briefed about the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study Protocol: a Randomized Crossover Controlled Human Volunteer Trial Comparing Blind Manual Vs. Ultrasound-guided Pressure Point in Combat Medics
the goal of this clinical trial is to compare the effectiveness of manual pressure points (femoral and supra-clavicular) for hemorrhage control by military medics using either the traditional blind manual technique or an ultrasound guided technique in healthy human volunteers. The main question to answer is which technique provides better results with regard to cumulative flow cessation during a 180 seconds attempt.
Participants will press on each other's supraclavicular and femoral pressure points, twice each, once with an ultrasound probe and once with their hand, while distal flow is measured using ultrasound doppler.
Read the detailed description
Each experimental day will include a maximum of 30 male subjects. Following the signing of an informed consent form and a questionnaire detailing possible exclusion criteria, subjects' demographics including age, gender, weight and height will be recorded. Right- or left-hand dominance, as well as the duration of service and previous training in MPP, will be determined by questioning and documented. This will be performed in a separate setting, ensuring subjects' privacy.
Then, all participants will undergo hands-on training in small groups concerning the pressure point technique - both blind application and ultrasound-guided application of the technique. Each participant will have the opportunity to try each technique at least once at each point.
Following the training session, participants will serve as both providers and models based on convenience (the order in which they approach the enrollment station), with each provider ideally becoming the subject for the next provider, although not necessarily. Each subject (medic) will perform two sets of attempts for pressure points application, on the same side of the model subject, which will be randomly determined (to avoid a bias created by the convenience of approach correseponding with providers' hand dominance). Before each set, the model subject's blood pressure and heart rate will be measured (on the contralateral side to the pressure application) and recorded. Each set will consist of three 180 seconds long attempts. Each attempt will be performed at a different point: Supraclavicular and femoral, with at least 120 seconds break between attempts. One of the sets will be performed using the blind, manual technique, using the provider's hands, and the other sets will be done using an ultrasound device guiding the location, direction and amount of pressure and using the probe itself to exert the pressure. The order in which the sets will be performed will be randomly determined.
At any point, any of the subjects can stop and end the attempt due to discomfort or any other reason. His participation will cease immediately, without the need for an explanation or taking any steps on his part. In that case, the same attempt (e.g. blind supraclavicular pressure) will not be repeated. However, this will not preclude the subject from participating in the following attempts as long as he is willing to.
At the end of each attempt, both the model and provider will be requested to rate their level of discomfort between 0 and 10 (NRS - Numerical Rating Score) During each attempt (including a 10-second baseline recording before each attempt), a sonographer will use a second ultrasound device to monitor blood flow distal to the pressure point using pulse-wave doppler. The sonographer will be blinded to the pressure technique used by the participant using a fabric blind and noise-cancelling headphones. The sonographer will vocally declare each time occlusion has been achieved or lost. A member of the experiment team will use a stopwatch to measure the total time of flow within each 180 seconds attempt. In addition, screen recording of the ultrasound device screen will be performed to allow for retrospective flow rate analysis using image analysis software. Screen recording of the pressing ultrasound screen will also be performed for potential retrospective analysis. Following each attempt, the cross-sectional area and mean flow rate of the artery in the intended pressure location will be measured by a sonographer to determine baseline flow through the artery, and clips will be collected to map the anatomy of the area for possible future analysis. This will be done after the attempt so that no markings will be left to guide the providers in their attempt.
- Conditions
- Junctional Hemorrhage, Extremity Hemorrhage
- Being tested
- Manual Pressure Point
- Keywords
- Pressure Point, Junctional Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Pressure PointOther
Compression of the subclavian artery against the 1st rib and of the common femoral artery against the pelvis.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided | Active comparator | Pressure on the subclavian artery against the 1st rib and on the common femoral artery against the pelvis for 3 minutes using an ultrasound probe visualizing the arteries, the underlying bones and the compression of the arteries. Receives: Other: Manual Pressure Point |
| Blind techniques | Active comparator | Pressure on the subclavian artery against the 1st rib and on the common femoral artery against the pelvis for 3 minutes using the medic's hand based on anatomical land marks and palpation of pulse. Receives: Other: Manual Pressure Point |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative flow time
The primary outcome for each attempt will be the cumulative flow time as a percentage of the 180 seconds attempt time.
Measured: 180 seconds
Secondary outcomes (1)
cumulative flow
A secondary outcome will be the calculated cumulative flow through the compressed point during each attempt
Measured: 180 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start20 Aug 2023
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Junctional HemorrhageStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Medical Corps, Israel Defense Force
- Responsible party
- Principal investigator, Barak Cohen, MD, Tel-Aviv Sourasky Medical Center
- Investigators
- Guy Avital, MD, Study director, Israel Defense ForcesOfer Almog, MD, Study director, Israel Defense Forces
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06007209
- Sponsor's protocol ID
- 2375-2023
- Status last verified
- Nov 2024
- First submitted
- 17 Aug 2023
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Protocol: a Randomized Crossover Controlled Human Volunteer Trial Comparing Blind Manual Vs. Ultrasound-guided Pressure Point in Combat Medics
- ClinicalTrials.gov ID
- NCT06007209
- Acronym / sponsor ID
- 2375-2023
- Conditions
- Junctional Hemorrhage, Extremity Hemorrhage
- Keywords
- Pressure Point, Junctional Hemorrhage
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Medical Corps, Israel Defense Force
- Study start
- 20 Aug 2023 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 23 Aug 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 the effectiveness of manual pressure points (femoral and supra-clavicular) for hemorrhage control by military medics using either the traditional blind manual technique or an ultrasound guided technique in healthy human volunteers. The main question to answer is which technique provides better results with regard to cumulative flow cessation during a 180 seconds attempt.
Participants will press on each other's supraclavicular and femoral pressure points, twice each, once with an ultrasound probe and once with their hand, while distal flow is measured using ultrasound doppler.
Detailed description
Each experimental day will include a maximum of 30 male subjects. Following the signing of an informed consent form and a questionnaire detailing possible exclusion criteria, subjects' demographics including age, gender, weight and height will be recorded. Right- or left-hand dominance, as well as the duration of service and previous training in MPP, will be determined by questioning and documented. This will be performed in a separate setting, ensuring subjects' privacy.
Then, all participants will undergo hands-on training in small groups concerning the pressure point technique - both blind application and ultrasound-guided application of the technique. Each participant will have the opportunity to try each technique at least once at each point.
Following the training session, participants will serve as both providers and models based on convenience (the order in which they approach the enrollment station), with each provider ideally becoming the subject for the next provider, although not necessarily. Each subject (medic) will perform two sets of attempts for pressure points application, on the same side of the model subject, which will be randomly determined (to avoid a bias created by the convenience of approach correseponding with providers' hand dominance). Before each set, the model subject's blood pressure and heart rate will be measured (on the contralateral side to the pressure application) and recorded. Each set will consist of three 180 seconds long attempts. Each attempt will be performed at a different point: Supraclavicular and femoral, with at least 120 seconds break between attempts. One of the sets will be performed using the blind, manual technique, using the provider's hands, and the other sets will be done using an ultrasound device guiding the location, direction and amount of pressure and using the probe itself to exert the pressure. The order in which the sets will be performed will be randomly determined.
At any point, any of the subjects can stop and end the attempt due to discomfort or any other reason. His participation will cease immediately, without the need for an explanation or taking any steps on his part. In that case, the same attempt (e.g. blind supraclavicular pressure) will not be repeated. However, this will not preclude the subject from participating in the following attempts as long as he is willing to.
At the end of each attempt, both the model and provider will be requested to rate their level of discomfort between 0 and 10 (NRS - Numerical Rating Score) During each attempt (including a 10-second baseline recording before each attempt), a sonographer will use a second ultrasound device to monitor blood flow distal to the pressure point using pulse-wave doppler. The sonographer will be blinded to the pressure technique used by the participant using a fabric blind and noise-cancelling headphones. The sonographer will vocally declare each time occlusion has been achieved or lost. A member of the experiment team will use a stopwatch to measure the total time of flow within each 180 seconds attempt. In addition, screen recording of the ultrasound device screen will be performed to allow for retrospective flow rate analysis using image analysis software. Screen recording of the pressing ultrasound screen will also be performed for potential retrospective analysis. Following each attempt, the cross-sectional area and mean flow rate of the artery in the intended pressure location will be measured by a sonographer to determine baseline flow through the artery, and clips will be collected to map the anatomy of the area for possible future analysis. This will be done after the attempt so that no markings will be left to guide the providers in their attempt.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided | Active comparator | Other: Manual Pressure PointPressure on the subclavian artery against the 1st rib and on the common femoral artery against the pelvis for 3 minutes using an ultrasound probe visualizing the arteries, the underlying bones and the compression of the arteries. |
| Blind techniques | Active comparator | Other: Manual Pressure PointPressure on the subclavian artery against the 1st rib and on the common femoral artery against the pelvis for 3 minutes using the medic's hand based on anatomical land marks and palpation of pulse. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age > 18 years.
- Combat pararescue medics who have completed their medics training course.
- Informed consent.
Key exclusion criteria (4 listed)
- Any medical condition that causes or may cause discomfort during the experiment, including specifically conditions involving the groin, shoulder and neck.
- Any known vascular disease, including any known familial hypercoagulability disorder.
- Any known peripheral neuropathy.
- All of the above will be based on subjects' self-reporting. Subjects will be encouraged to consult with the unit's physician who will not be part of the study team but will be briefed about the study protocol.
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 |
|---|---|---|
| Manual Pressure PointCompression of the subclavian artery against the 1st rib and of the common femoral artery against the pelvis. | Other | Blind techniques, Ultrasound guided |
Primary outcome
cumulative flow time
Time frame: 180 seconds
The primary outcome for each attempt will be the cumulative flow time as a percentage of the 180 seconds attempt time.
1 secondary outcome
cumulative flow
Time frame: 180 seconds
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Guy Avital, MD study director
Israel Defense Forces
Ofer Almog, MD study director
Israel Defense Forces
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Pressure Point in people with Junctional Hemorrhage and Extremity Hemorrhage, run by Tel-Aviv Sourasky Medical Center 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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 22 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cumulative flow time (time frame: 180 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 22 Nov 2024.