Feasibility and Accuracy of the Accuro 3S
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mean number of needle attempts
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: ACCURO 3S (Device)
结局指标
主要结局
Mean number of needle attempts
时间窗: At time of procedure, 1 day
Defined as the number of times the needle is inserted into patients back
Mean number of needle redirections
时间窗: At time of procedure, 1 day
Defined as number of needle movements in a cephalad, caudal or lateral position.
Accuracy of device
时间窗: 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).
次要结局
- Patient satisfaction(20 minutes post procedure)