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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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).
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Tel Aviv
-
Tel Aviv, Tel Aviv, Israel
- Tel Aviv Medical Center
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Viabilidade do dispositivo
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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) |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
success in achieving blood flow occlusion by compressing the abdominal aorta
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Cumulative flow time in the femoral artery
Prazo: 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.
Prazo: Up to 30 seconds
|
Time required for achievement of full occlusion.
|
Up to 30 seconds
|
|
Time required to obtain the desired sonographic view.
Prazo: Up to 120 seconds
|
Time required to obtain the desired sonographic view.
|
Up to 120 seconds
|
|
Particiapant discomfort score (NRS).
Prazo: maximal within the 30 seconds attempt
|
Particiapant discomfort score (NRS).
|
maximal within the 30 seconds attempt
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 0134-25-TLV
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
produto fabricado e exportado dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .