Does the Use of Both Palpation and Accuro as Compared to Palpation Alone or Use of Accuro Alone in a Single Patient Increase the First Pass Success Rate in Placing Spinals or Combined Spinal Epidurals for Cesarean Sections.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- success rates
研究概览
简要总结
The Accuro is a three dimensional handheld ultrasound device. This device uses sound waves to create pictures of the spine in three dimensions. This may allow the physician to view the spine in more detail for procedures such as spinal anesthesia and other diagnostic procedures.
We aim to assess the benefit of using both the Accuro and traditional landmark palpation technique to determine accurate spinal level in women who undergo cesarean section. This study will also assess provider preference for use of both Accuro and palpation compared with palpation alone or use of Accuro alone.
Anesthesia Providers will first identify the L4/L5 space using the traditional technique of palpating the iliac crests to estimate spinal level, which will be marked with a single dot from a marking pen. The provider will then use the Accuro 3000 to identify the L4/L5 interspace.
Results will be compared to results obtained in IRB 18070 "Handheld 3D lumbar spine navigation: A clinical validation study RM002" where subjects who were undergoing a C-section were randomized to either palpation or Accuro alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
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
- •• Patients between the ages of 18 and 45 presenting for a C-section delivery or scheduled for elective Cesarean section
- •ASA-1, ASA-2, and ASA-3
- •Patients with no known back deformities
- •Ability to sit upright for spinal placement
- •No prior lumbar surgery
- •No allergies to ultrasound gel
排除标准
- •• Unable or unwilling to give informed consent
研究组 & 干预措施
Palpation and Accuro
The placement site for the spinal anesthesia will be identified using both palpation and Accuro.
干预措施: Palpation and Accuro (Device)
结局指标
主要结局
success rates
时间窗: Day 1
Success rates: defined as successful spinal administration on the first needle insertion attempt.
次要结局
- Level of spinal placement: a record of the vertebral level where the spinal is administered.(Day 1)
研究者
Mohamed Tiouririne, MD
Associate Professor
University of Virginia
