Precisão do Accuro 3S
Viabilidade e Precisão do Accuro 3S
The main purpose of this study is to evaluate the feasibility and accuracy of the Accuro 3S to provide live guidance when performing a neuraxial technique (e.g., spinal, or epidural).
The Accuro 3S is a new device that was designed to allow for midline live neuraxial guidance. If the device can perform as the manufacturers claim the device will permit the performance of epidurals as close as doing them under fluoroscopy.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Feasibility will be assessed in terms of how easily the device can be used and if it poses any discomfort to the patient. Live guidance is defined as the ability to see and change, if needed, the needle trajectory as it is advanced. Accuracy is defined as a measurement of depth by device versus the actual depth of the needle, number of needle attempts (skin punctures) and number of needle redirection.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Antonio Gonzalez-Fiol, MD
- Número de telefone: 203-785-2802
- E-mail: antonio.gonzalez-fiol@yale.edu
Locais de estudo
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06520
- Yale New Haven Hospital
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- The anesthetic plan for the patient includes a neuraxial anesthetic (spinal or epidural) as the main anesthetic for labor, surgery (e.g. orthopedic surgery, cesarean delivery) or for postoperative pain management (e.g, major abdominal surgery). *Given our labor and delivery volume (~300 epidurals/month) investigators think that they will only recruitc obstetric patients. In case of difficulty recruiting, then investigators will seek out a different patient population.
- No history of allergic reactions to adhesives used in standard epidural placements as per chart review or self-reported.
- Patient skin is intact in the area of placement of the epidural or spinal anesthesia.
- The patient is English speaking.
- For obstetric patients, the patient is admitted for cesarean delivery or for induction and is not in active labor. *Clarification - Patients scheduled for elective cesarean delivery will be approached for spinal anesthesia. Given that spinal anesthesia carries a smaller risk for post-dural puncture headache and other morbidities, investigators will recruit and perform 10 spinals on this patient population. Once comfortable with the technology, then will move to recruiting and performing epidurals. If during the spinal anesthesia trial the device does not provide accurate and clear needle visualization, the study will be culminated.
Exclusion Criteria:
- Contraindication to epidural catheter placement including bleeding diathesis (essential thrombocythemia, idiopathic thrombocytopenic purpura, von Willebrand disease, and hemophilia A or B), neurological dysfunction (multiple sclerosis, subacute myeloopticoneuropathy or preexisting lower limb neurological deficit), prior extensive spinal surgery or major spinal deformity, pre-operative use of anti-coagulant with planned use of therapeutic dose of anti-coagulant in post-operatively, documented pre-operative coagulopathy (INR greater than 1.3 not on Coumadin or PTT greater than 42), platelets less than 100, 000, or evidence of infection at potential epidural site.
- Presence of orthopedic implants in the spine.
- Skin dyscrasias or allergies to the ultrasound procedure.
- Unable to assume sitting position.
- Body Mass Index (BMI) less than 18.5 kg/m2.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Standard of Care and neuraxial guidance
Spinal or Epidural will be performed utilizing neuraxial guidance and standard of care techniques for placement. The spinal or epidural technique will not deviate from the standard of care. The device will only add the use of the disposable sterile drape and the use of the image will guide change of needle trajectory (without the need for contrast or radiation exposure) but not changing the technique. |
Provides anatomical guidance during the placement of needles or catheters using real-time visualization. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Mean number of needle attempts
Prazo: At time of procedure, 1 day
|
Defined as the number of times the needle is inserted into patients back |
At time of procedure, 1 day
|
|
Mean number of needle redirections
Prazo: At time of procedure, 1 day
|
Defined as number of needle movements in a cephalad, caudal or lateral position. |
At time of procedure, 1 day
|
|
Accuracy of device
Prazo: At time of procedure, 1 day
|
The ultrasound device can be used to measure the distance from skin to epidural space, this will be recorded as the estimated distance to epidural space (EDES). Once the epidural space is accessed the needle will be marked and measured. This will represent the Distance to epidural space (DES). The difference between EDES and DES will provide the accuracy of the device. Mean distance in centimeters (cm). |
At time of procedure, 1 day
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Patient satisfaction
Prazo: 20 minutes post procedure
|
Likert scale asking the patient "How satisfied are you with the procedure performed?" Very dissatisfied, dissatisfied, Satisfied, very satisfied, extremely satisfied. Total score range 1-5 with higher scores indicating more satisfaction. |
20 minutes post procedure
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Antonio Gonzalez-Fiol, MD, Yale University
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2000036235
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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