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
Feasibility Study of Ultrasound Guided Aortic Compression for Arresting Abdominal Aortic Blood Flow in Healthy Volunteers
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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:
- Success in aortic occlusion (binary).
- Time to first achievement of aortic occlusion (seconds).
- Percent of time of the test time with successful aortic occlusion (%).
- 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:
- Cumulative flow time in the femoral artery (failure of occlusion) as a percentage of the 30 seconds attempt time
- Time required for achievement of full occlusion.
- Time required to obtain the desired sonographic view.
- Particiapant discomfort score (NRS).
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Tel Aviv
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Tel Aviv, Tel Aviv, Israël
- Tel Aviv Medical Center
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-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Toestel Haalbaarheid
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Single Arm
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).
|
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) |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
success in achieving blood flow occlusion by compressing the abdominal aorta
Tijdsspanne: Within 30 seconds
|
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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Cumulative flow time in the femoral artery
Tijdsspanne: Over 30 seconds
|
Cumulative flow time in the femoral artery (failure of occlusion) as a percentage of the 30 seconds attempt time
|
Over 30 seconds
|
|
Time required for achievement of full occlusion.
Tijdsspanne: Up to 30 seconds
|
Time required for achievement of full occlusion.
|
Up to 30 seconds
|
|
Time required to obtain the desired sonographic view.
Tijdsspanne: Up to 120 seconds
|
Time required to obtain the desired sonographic view.
|
Up to 120 seconds
|
|
Particiapant discomfort score (NRS).
Tijdsspanne: maximal within the 30 seconds attempt
|
Particiapant discomfort score (NRS).
|
maximal within the 30 seconds attempt
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 0134-25-TLV
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