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 Katballe7 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2012年4月最近更新:
适应症
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
- 7
- 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
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 (7)
Loading locations...
相似试验
Unknown
2 期
Safety and Efficacy Study of an Interactive Wound Dressing (KC002) for the Treatment of Diabetic Foot UlcersFoot UlcerDiabetesNCT00330265KeraCure300
已完成
不适用
Effectiveness of Catheter Reminder and Evaluation ProgramAll Hospitalized PatientsWith and Without CatheterNCT01797146Siriraj Hospital874
已完成
3 期
Phase III Cat-PAD Follow-on StudyCat AllergyNCT02040844Circassia Limited430
已完成
不适用
A Pilot Study Evaluating the Safety and Effectiveness of a New Pleural Catheter for the Medical Management of Symptomatic, Recurrent, Malignant Pleural EffusionsMalignant Pleural EffusionsNCT02227732C. R. Bard10
已完成
不适用
Decision Aid - Extreme PrematurityDecision Support PrematurityNCT01713894Christiana Care Health Services200