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

NCT07707921 | Not Yet Recruiting DMC

• 1 other identifier: 0134-25-TLV
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

Aortic Compression

Outcome Measures

Primary Outcomes (1)

• success in achieving blood flow occlusion by compressing the abdominal aorta

  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.

  Within 30 seconds

Secondary Outcomes (4)

• Cumulative flow time in the femoral artery

  Over 30 seconds

• Time required for achievement of full occlusion.

  Up to 30 seconds

• Time required to obtain the desired sonographic view.

  Up to 120 seconds

• Particiapant discomfort score (NRS).

  maximal within the 30 seconds attempt

Study Arms (1)

Single Arm

EXPERIMENTAL

An 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).

Device: An Ultrasound Guided Aortic Compression for Arresting Abdominal Aortic Blood Flow

Interventions

An Ultrasound Guided Aortic Compression for Arresting Abdominal Aortic Blood Flow DEVICE

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). 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)

Single Arm

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-40 years.
• Informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead
• Medical Corps, Israel Defense Force: collaborator

Study Sites (1)

Tel Aviv Medical Center

Tel Aviv, Tel Aviv, Israel

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2026
• First Posted: July 16, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 11, 2027
• Study Completion (Estimated): August 11, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

IL (1)