Real Time 3D Navigation and Traditional US to Identify Epidural Space Depth in Obese Pregnant
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
- Epidural space depth
研究概览
简要总结
The aim of this study is to assess the accuracy of the Accuro Ultrasound Device in estimating the epidural space depth compared to the Standard Ultrasound Examination and with the measured needle depth during epidural and spinal insertion in pregnant obese patients
详细描述
SpineNav3DTM technology facilitates image interpretation of individual 2D lumbar spine scans by automating spinal bone landmark detection and depth measurements and providing a real-time assessment of scan plane orientation in 3D.
All the subjects will have their lumbar area scanned for the measurements of the depth of the epidural space (recorded in cm) by two blinded anesthesiologists, one using standard ultrasounds and the other the Accuro Device.
All measurements will be performed either in the sitting or in the supine position at L1/L2, L2/L3 and L3/L4 levels. Neuraxial anesthesia will be performed by using the previously marked interspace by a blinded anesthesiologist who will measure the epidural space depth during epidural or spinal insertion by marking the needle.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA Status >III
- •obese BMI>30
- •term gestatio > 37 weeks
- •singleton pregnancy
- •undergoing elective cesarean section with spinal anesthesia
- •requesting epidural labor analgesia
排除标准
- •contraindications to neuraxial block
- •severe scoliosis
- •previous spine surgery
结局指标
主要结局
Epidural space depth
时间窗: up to 30 minutes
the depth of the epidural space (recorded in cm) is defined as the distance from the skin to the posterior complex
次要结局
未报告次要终点