NCT01522885已完成3 期
KatGuide-trial. KatGuide Method Versus Conventional Method at Insertion of Chest Tube. A Randomized, Parallel Group, Controlled Trial.
Niels Katballe4 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2012年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 4
- 主要终点
- Chest tube placement
研究概览
简要总结
The purpose of this study is to investigate whether if KatGuide (a new developed medical device) improves the placing of a large bore chest tube in the pleural cavity compared to the conventional method.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pneumothorax in the upper pleural space or fluid in the lower pleural space.
- •Indication for upper or lower placement of a single chest tube in the pleural cavity
- •18 years of age or older
排除标准
- •Fertile women
- •Patients who can not give written or verbal consent to participate
- •If there is no time or possibility to inform the patient
- •Patients who already has a large bore chest tube
- •Patients with long lasting (>14 days) or chronic chest tube
- •Patients with both fluid and air in the pleural cavity
- •Patients where "the safe area" (front axillary fold, IC 4-5) can not be used for chest tube insertion
研究组 & 干预措施
KatGuide
Active Comparator
Chest tube insertion is performed by using the KatGuide
干预措施: KatGuide versus conventional method (forceps) (Device)
Conventional group
Active Comparator
Chest tubes are inserted by using conventional method (forceps) for large bore chest tube insertion.
干预措施: Chest tube insertion (Procedure)
结局指标
主要结局
Chest tube placement
时间窗: 3 hours
X-ray examination of the chest is performed within 3 hours after the chest tube insertion, to evaluate if the placement of the chest tube is acceptable.
次要结局
- Length of hospital stay(5 days)
- Time with chest tube(3 days (mean time))
- Infection in wound(4 weeks)
- Number of chest tubes(7 days (mean time))
研究者
Niels Katballe
Coordinating investigator, MD, PhD
University of Aarhus
研究点 (4)
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