Insufflation With Carbon Dioxide Reduces Pneumoperitoneum After Percutaneous Endoscopic Gastrostomy (PEG): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Post-procedure pneumoperitoneum
研究概览
简要总结
The investigators hypothesize that using carbon dioxide for PEG placement versus using room air will decrease post-procedure pneumoperitoneum as well as improve post-procedure bloating/pain, and waist circumference.
详细描述
Background and study aims: Pneumoperitoneum following PEG placement has been reported in up to 60% of cases, and while usually benign and self-limited, it can lead to evaluation for suspected perforation. This study was designed to determine whether using CO2 compared to ambient air for insufflation during PEG reduces post-procedure pneumoperitoneum.
Patients and Methods: Prospective, double blind, randomized trial of 35 consecutive patients undergoing PEG at a single academic medical center. Patients were randomized to insufflation with CO2 or ambient air. Primary outcome was pneumoperitoneum determined by left-lateral decubitus abdominal x-rays 30 min after PEG placement. Secondary endpoints included abdominal distention, pain, and bloating.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
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
- •Participants must be over the age of 18 and need a percutaneous endoscopic gastrostomy
排除标准
- 未提供
结局指标
主要结局
Post-procedure pneumoperitoneum
时间窗: left-lateral decubitus abdominal x-rays 30 min after PEG placement.
Frequency of post pneumoperitoneum determined by left-lateral decubitus abdominal x-rays 30 min after PEG placement.
次要结局
未报告次要终点
研究者
John C. Fang, M.D.
Chief, Division of Gastroenterology, Hepatology and Nutrition
University of Utah