NCT01537289Unknown3 期
A Prospective Randomized Study of 14-French (14F) Pigtail Catheters Versus 28F Chest Tubes in Patients With Traumatic Pneumothorax: Impact on Tube-Site Pain and Failure Rate
适应症
干预措施
试验速览
- 阶段
- 3 期
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Change in Tube-site pain, pain medication requirement
研究概览
简要总结
A small 14-French(F) pigtail catheter (PC) has been shown to work equally well with traditional 32-40F chest tube (CT), especially in traumatic pneumothorax.
There are no clinical data on tube-site pain. The investigators hypothesize that PC tube site pain is less than CT.
详细描述
Primary outcome: - Tube site pain
- Pain medication requirement
Secondary outcome: failure rate insertion-related complication
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years old and above
- •Suffer traumatic pneumothorax that requires chest tube insertion
排除标准
- •Emergency chest tube insertion
- •patient refuses
- •patient is unable to provide or rate pain assessment
- •pregnancy
- •patient with GCS less than 13
研究组 & 干预措施
Pigtail catheter
Experimental
干预措施: Pigtail catheter insertion (Cook) (Device)
Traditional chest tube
Active Comparator
28-French chest tube
干预措施: chest tube (28-French) (Device)
结局指标
主要结局
Change in Tube-site pain, pain medication requirement
时间窗: day 0, 1, 2
次要结局
- failure rate(patients will be followed for the duration of hospital stay, an expected average of 2 weeks)
- Insertion-related complication(day 0)
研究者
Narong Kulvatunyou
Assistant Professor
University of Arizona
研究点 (1)
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