NCT06305260Enrolling By Invitation不适用
The LOTUS Trial: Lumbar Ultrasound Utility in Obstetric Patients With BMI > 40
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Epidural Redirects
研究概览
简要总结
The goal of this clinical trial is to compare traditional palpation to pre-procedural lumbar ultrasound prior to epidural placement in obese (BMI >40) obstetric patient population. The main questions it aims to answer are:
- Is a pre-procedural lumbar ultrasound superior to traditional palpation in terms of total number of epidural needle redirections during epidural placement?
- Is there no difference in time to epidural loss between pre-procedural lumbar ultrasound and traditional palpation during epidural placement? Participants will be randomized to either a pre-procedural lumbar ultrasound or traditional palpation at the time of epidural placement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years or older
- •English Speaking
- •BMI (Body Mass Index) > 40
- •Ability to provide informed consent and verbally disclose their medical history
排除标准
- •History of spine surgery, scoliosis, or other spinal abnormality which could complicate epidural placement
- •Patients with platelet counts <70,000 or patients who are on anticoagulation, or patients who are on anticoagulation, both would exclude any patient from receiving an epidural.
- •Adults unable to make their own decisions or with cognitive issues or developmental delays
- •Prisoners
研究组 & 干预措施
Traditional Lumbar Palpation
No Intervention
This group will include parturients who are randomized to traditional lumbar palpation prior to epidural placement. This is the current standard of care.
Pre-procedural Lumbar Ultrasound
Experimental
This group will include parturients who are randomized to a pre-procedural lumbar ultrasound prior to epidural placement.
干预措施: Lumbar Ultrasound (Diagnostic Test)
结局指标
主要结局
Epidural Redirects
时间窗: Day of Epidural
Total number of epidural needle redirections
次要结局
- Total time to epidural space(Day of Epidural)
- Number of attempts at a different level(Day of Epidural)
- Epidural replacement rate(Day of Epidural)
- Patient satisfaction(24 hours post-epidural)
研究者
研究点 (2)
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