Utilizing Ultrasound for Residents as an Aid in Epidural Placement
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Success Rate
研究概览
简要总结
This randomized controlled trial will evaluate the use of ultrasound as an aid for epidural placement in residents performing all epidural techniques under direct staff anesthesiologist supervision.
详细描述
The purpose of this study is to assess the abilities of the "Accuro" to assist in lumbar epidural placement in patients. It is hypothesized that the use of the Accuro will result in an increase of first-attempt success rates, defined as successful epidural needle placement on the first needle insertion attempt.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients presenting for vaginal delivery
- •ASA-1, ASA-2, and ASA-3
- •Patients with no known back deformities
- •Ability to sit upright for epidural placement
- •No prior lumbar surgery
- •No allergies to ultrasound gel
- •Pre-pregnancy BMI >= 30
排除标准
- •Patients < 18 years of age
研究组 & 干预措施
Standard Epidural
Participants in this group will have epidurals placed using standard practice.
干预措施: Standard Epidural (Procedure)
Ultrasound Guided Epidural
Participants in this group will have epidurals placed using standard practice with the assistance of ultrasound.
干预措施: Ultrasound Guided Epidural (Device)
结局指标
主要结局
Success Rate
时间窗: Baseline (at time of procedure)
Success rates are defined as successful epidural administration on the first needle insertion attempt. This outcome will be a dichotomous (yes/no) outcome.
次要结局
- Time to landmark identification(Baseline (at time of procedure))
- Total technical procedure time(Baseline (at time of procedure))
- Pain(Baseline (at time of procedure))
- Analgesia efficacy rate(Baseline (at time of procedure))
- Needle passes(Baseline (at time of procedure))
- Needle insertion attempts(Baseline (at time of procedure))
- Accuracy of needle insertion(Baseline (at time of procedure))
- Vertebral level of epidural placement(Baseline (at time of procedure))
- Epidural space depth(Baseline (at time of procedure))
- Time to loss of resistance(Baseline (at time of procedure))
- Time to complete epidural analgesia administration(Baseline (at time of procedure))
- Time to comfort(Baseline (at time of procedure))
- Patient satisfaction(Follow Up (Up to 1 day))