Accuracy of Depth and Landmark Assessment Using Neuraxial Ultrasound Devices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Depth to Epidural Space
研究概览
简要总结
The purpose of this study is to determine if a handheld ultrasound device helps in the placement of labor epidurals by studying the accuracy of the Accuro Handheld Ultrasound device compared to a standard ultrasound machine.
详细描述
Pregnant women who present to Labor and Delivery for an anticipated vaginal delivery will be identified as potential participants based on inclusion/exclusion criteria and their desire for labor epidural analgesia. Ultrasound evaluations will be conducted in a cohort of 50 parturients who decide they want epidural analgesia in labor. Prior to epidural placement, a hand held ultrasound device will be utilized to identify L2/3, L3/4 and L4/5 interspace. A mark will be made on the patient's back at these levels. The handheld ultrasound device will also estimate the depth to epidural space at each level using its programmed algorithm. A standard ultrasound will then be used to locate the same interspaces, identify midline, and estimate depth to epidural space with caliper calculation. Upon patient request, an epidural will be placed at L3/4 with a loss of resistance to saline technique. The actual depth to loss of resistance during epidural insertion will be determined by measuring the Tuohy with a sterile measuring tape while it is in the skin.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists physical status class I, II, or III
- •age between 18 and 50
- •singleton term pregnancy
- •requesting epidural analgesia for anticipated vaginal delivery
- •all ethnicities
排除标准
- •contraindication for epidural analgesia (bleeding diathesis, neuropathy, severe scoliosis, previous spine surgery, local anesthetic allergy)
- •inability to adequately understand the consent form
结局指标
主要结局
Depth to Epidural Space
时间窗: Within 24 Hours of enrollment
Determine the difference between the Accuro ultrasound epidural space depth estimation and actual Tuohy epidural depth during epidural insertion at L3/4
次要结局
- Epidural Failure Rate(Within 24 Hours of enrollment)
- Time to Epidural Placement(Within 24 Hours of enrollment)
- Interspace Identification(Within 24 Hours of enrollment)
- Midline Identification(Within 24 Hours of enrollment)
- Interspace Levels Attempts(Within 24 Hours of enrollment)
研究者
Brendan Carvalho
Chief of Obstetric Anesthesia, Professor - Department of Anesthesiology
Stanford University