Real-time Spine Ultrasound Imaging System: Data Collection Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Incidence of difficult block placement
研究概览
简要总结
The aim of the study is to develop a device that can eliminate failed neuraxial placements in challenging patients.The study will attempt to improve safety and efficacy of neuraxial anesthesia with high precision real-time needle visualization through automated real-time needle guidance at the bedside with an experimental device (Accuro 3S). Investigators will verify the clinical workflow for utilizing the Accuro 3S during epidural and spinal procedures and validation of needle visualization while using the device as well as anatomical guidance provided by the device during spinal imaging.The underlying bone imaging enhancement algorithms were introduced in the commercially available FDA approved Accuro. The Accuro 3S will be used to establish needle insertion point and trajectory, after which the clinician will use standard of care methods to advance the needle such as the loss of resistance method.
详细描述
This is a prospective, structured observational study (data collection study) in which Investigators enroll patients who are scheduled for neuraxial anesthesia procedures.
Qualified subjects will be identified and contacted by the anesthesia team prior to their clinical evaluation for labor neuraxial analgesia. Potential patients will be informed of the study, and if study individuals choose to participate and an informed consent form will be signed prior to any study related activities.
When study participants request labor analgesia, investigators will incorporate routine care delivery flow for patients receiving ultrasound guided neuraxial anesthesia.
The clinician will apply ultrasound gel to the Accuro 3S probe (gel inside the probe need not be sterile), and then cover the probe in a sterile probe cover. Sterile ultrasound gel will then be applied to the patient's skin on the back to enable imaging. The Accuro 3S probe will be applied to the patient's spinal region and the clinician will perform scouting scans. Image recordings can be captured by depressing a button located on the probe handle. While performing the scouting scans, the provider will take several image recordings of the spine. The image recordings will include two levels, finding the space, and then at each level plus a spinous process, scanning left and right at each of these points.
The clinician will then administer local anesthetic prior to needle procedures. After needle insertion point and trajectory is established on the ultrasound image, the epidural or spinal needle will then be advanced by the clinician based on their standard technique. While advancing the needle the provider will collect a series of image recordings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older
- •The patient is eligible for placement of neuraxial anesthesia, and the patient has agreed to the procedure.
- •Patient skin is intact in the area of placement of the epidural or spinal anesthesia.
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 70,000/μL, 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 20 kg/m
- •Known allergies to ultrasound gel.
- •Known history of allergic reactions to adhesives used in standard epidural placement
研究组 & 干预措施
Intrathecal neuraxial procedure
Participants undergoing surgery, receiving neuraxial intrathecal anesthesia with block placement in part by the investigational device.
干预措施: Ultrasound placement device (Device)
结局指标
主要结局
Incidence of difficult block placement
时间窗: 15 minutes
Difficult block placement is defined by need of \> 2 needle insertion attempts for succesful neuraxial analgesia/anesthesia
次要结局
- Incidence of post-dural puncture headache(7 days)
- Incidence of failed block(30 minutes)
研究者
Clemens Ortner
Clinical Associate Professor
Stanford University