The Effects of Fixation Technique on Thoracic Epidural Catheter Displacement: a Single-Center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Epidural catheter displacement day 1
研究概览
简要总结
The purpose of our study is to assess the effectiveness of Dermabond as a thoracic epidural fixation technique compared to both Mastisol and the Grip-Lok fixation bandage, two common, widely used techniques for epidural fixation.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •surgical patient
- •receiving a thoracic epidural
- •18 years of age or older
排除标准
- •Patient refusal
- •allergy to adhesives or local anesthesia
- •pregnancy
- •contraindication to receiving an epidural including coagulopathy, infection, elevated ICP, or severe pre-existing neurologic disorders
结局指标
主要结局
Epidural catheter displacement day 1
时间窗: 24 hours post-operative
Failure of epidural fixation as measured by catheter depth at the skin (to the nearest 0.5 cm
Epidural catheter displacement day 2
时间窗: 48 hours post-operative
Failure of epidural fixation as measured by catheter depth at the skin (to the nearest 0.5 cm
Epidural catheter displacement immediately after surgery
时间窗: immediately after surgery in PACU
Failure of epidural fixation as measured by catheter depth at the skin (to the nearest 0.5 cm
Epidural catheter displacement day 4
时间窗: 96 hours post-operative
Failure of epidural fixation as measured by catheter depth at the skin (to the nearest 0.5 cm
Epidural catheter displacement day 3
时间窗: 72 hours post-operative
Failure of epidural fixation as measured by catheter depth at the skin (to the nearest 0.5 cm
Epidural catheter displacement day 5
时间窗: 120 hours post-operative
Failure of epidural fixation as measured by catheter depth at the skin (to the nearest 0.5 cm
Epidural catheter displacement day 7
时间窗: 168 hours post-operative
Failure of epidural fixation as measured by catheter depth at the skin (to the nearest 0.5 cm
Epidural catheter displacement day 6
时间窗: 144 hours post-operative
Failure of epidural fixation as measured by catheter depth at the skin (to the nearest 0.5 cm
次要结局
- Leakage(immediately after surgery in PACU and daily until the patient is discharged up to post-operative day 7)
- Percent of patients with skin changes as measured by clinician subjective assessment(immediately after surgery in PACU and daily until the patient is discharged up to post-operative day 7)
- Opioid consumption(daily up to 7 days post-operative)
研究者
Adam Meier
Associate Professor
University of Utah