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
Przegląd badań
Status
Warunki
Szczegółowy opis
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).
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Tel Aviv
-
Tel Aviv, Tel Aviv, Izrael
- Tel Aviv Medical Center
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Wykonalność urządzenia
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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) |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
success in achieving blood flow occlusion by compressing the abdominal aorta
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Cumulative flow time in the femoral artery
Ramy czasowe: 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.
Ramy czasowe: Up to 30 seconds
|
Time required for achievement of full occlusion.
|
Up to 30 seconds
|
|
Time required to obtain the desired sonographic view.
Ramy czasowe: Up to 120 seconds
|
Time required to obtain the desired sonographic view.
|
Up to 120 seconds
|
|
Particiapant discomfort score (NRS).
Ramy czasowe: maximal within the 30 seconds attempt
|
Particiapant discomfort score (NRS).
|
maximal within the 30 seconds attempt
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- 0134-25-TLV
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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