Pilot Clinical Trial of Ultrasound Guided Aortic Compression for Arresting Abdominal Aortic Blood Flow in Healthy Volunteers. This Isn't Device Feasibility, But Rather the Feasibility of a Clinical Maneuver; Specifically, Evaluating Whether the Technique Can Achieve the Anticipated Out
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: An Ultrasound Guided Aortic Compression for Arresting Abdominal Aortic Blood Flow.
- Who it may be relevant to
- Registry conditions: Healthy Volunteers. Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Feasibility Study of Ultrasound Guided Aortic Compression for Arresting Abdominal Aortic Blood Flow in Healthy Volunteers
Overview
As point-of-care ultrasound (POCUS) is becoming more available in the prehospital setting, it can be potentially used for more accurate and directed pressure application, thanks to its ability to image the artery and the underlying bony surface. The investigators therefore aim to conduct a feasibility study on healthy volunteers, to test the efficacy and tolerability of external abdominal compression using an ultrasound probe to obstruct blood flow in the abdominal aorta.
Detailed description
The aim of the study is to determine whether ultrasound-guided abdominal aortic compression is feasible as a method to stop distal blood flow.
Before the compression attempt, a research team member will use the first ultrasound device with a linear probe to locate the common femoral artery and measure the blood flow.
A second ultrasound device will be used to perform abdominal aortic pressure under vision. A curved probe will be placed on the upper abdomen, above the umbilicus, in the midline position and transverse orientation. The operator will have up to 2 minutes to obtain the desired sonographic view that allows for the compression to begin, with the middle of the probe, the abdominal aorta and the vertebra along the same line. Once the view is obtained, as declared by the operator and confirmed by a member of the study team, time required to obtain this view will be recorded, and recording of the common femoral blood flow will begin (for baseline) for 10 seconds, followed by 30 seconds of compression attempt (of which the compressing ultrasound view will also be recorded synchronously).the doppler graph will later be analyzed to determine the listed outcomes:
1. Success in aortic occlusion (binary). 2. Time to first achievement of aortic occlusion (seconds). 3. Percent of time of the test time with successful aortic occlusion (%). 4. Cumulativeflow reduction during the 30 seconds compression (%). At the end of the experiment, the participant will be requested to rate their level of discomfort between 0 and 10 (NRS - Numerical Rating Score)
The primary outcome will be success in achieving blood flow occlusion by compressing the abdominal aorta against lumbar vertebra as measured by no distal blood flow in the femoral artery, for any period within the 30 seconds of intervention.
Secondary outcomes will be:
1. Cumulative flow time in the femoral artery (failure of occlusion) as a percentage of the 30 seconds attempt time 2. Time required for achievement of full occlusion. 3. Time required to obtain the desired sonographic view. 4. Particiapant discomfort score (NRS).
Interventions
- Device An Ultrasound Guided Aortic Compression for Arresting Abdominal Aortic Blood Flow
A second ultrasound device will be used to perform abdominal aortic pressure under vision. A curved probe will be placed on the upper abdomen, above the umbilicus, in the midline position and transverse orientation. The operator will have up to 2 minutes to obtain the desired sonographic view that allows for the compression to begin, with the middle of the probe, the abdominal aorta and the vertebra along the same line. Once the view is obtained, as declared by the operator and confirmed by a me
Primary outcome measures
- success in achieving blood flow occlusion by compressing the abdominal aorta [Time frame: Within 30 seconds]
Secondary outcome measures (4)
- Cumulative flow time in the femoral artery [Time frame: Over 30 seconds]
- Time required for achievement of full occlusion. [Time frame: Up to 30 seconds]
- Time required to obtain the desired sonographic view. [Time frame: Up to 120 seconds]
- Particiapant discomfort score (NRS). [Time frame: maximal within the 30 seconds attempt]
Eligibility criteria
Inclusion criteria
- Age 18-40 years.
- Informed consent.
Exclusion criteria
- Any known abdominal or vascular pathology.
- Any known peripheral neuropathy.
- BMI>30.
- Sensitivity to ultrasonic gel.
- Tendency for syncope/ pre-syncope during blood-drawing, intravenous cannulation, etc.
- Personnel actively serving in the IDF.
- Pregnant/ possibly pregnant individuals.
- People lacking the ability to give informed consent.
- All of the above will be based on subjects' self-reporting. Subjects will be encouraged to consult with their physician.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
Israel · 1 center
- Tel Aviv Medical Center — Tel Aviv
Identifiers
NCT: NCT07707921 · 0134-25-TLV