NCT02165891Unknown3 期
Prospective Randomized Study Comparing the Efficacy and Safety of Pleural Drainage by Video-Assisted Thoracoscopic With Pleural Drainage by Percutaneous Drain Associated With Urokinase in the Treatment of Parapneumonic Pleural Effusion in Children
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- duration of drainage
研究概览
简要总结
Despite the improvement in the technology available for diagnosing and treating empyema, the management of empyema in children remains controversial.
The purpose of this study is to compare the efficacy and safety of two common technical approach used for pleural effusion drainage in the treatment of childhood empyema.
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
- None
入排标准
- 年龄范围
- 1 Year 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients under the age of 17
- •pleural fluid depth of at least 15mm, confirmed by ultrasound
- •at least one of the following severity criteria :
- •fever continuing 48h after starting correct antibiotherapy
- •respiratory distress
- •mediastinal displacement on the chest X-ray
排除标准
- •previous drainage by either Video-Assisted Thoracoscopic or pleural drainage by percutaneous drain associated with urokinase- congenital pulmonary disorders with lung function impairment
- •congenital pulmonary disorders with lung function impairment
- •chronic pulmonary disease associated with lung function impairment
- •hemodynamic instability
- •congenital immunodeficiency disease
- •secondary immune deficiency induced
- •hemostasis disorder (contraindication of thrombolytic therapy)
- •pregnancy or breastfeeding patient
研究组 & 干预措施
Urokinase
Other
insertion of a chest drain with urokinase instillation
干预措施: insertion of a chest drain with urokinase instillation (Drug)
VATS
Other
primary video-assisted thorascopic surgery Other interventions except drainage procedure are the same in both arms
干预措施: primary video-assisted thorascopic surgery (Procedure)
结局指标
主要结局
duration of drainage
时间窗: end of drainage defined per protocole as < 1ml/kg/24h with an expected average time of two days to seven days
次要结局
- Number of Participants with Serious and Non-Serious Adverse Events(Up to the end of the hospitalisation, until three months corresponding to the end of follow up period)
- Duration of oxygen therapy(up to the end of patient hospitalisation with an expected average time of 48 hours to five days)
- Patient discomfort(Up to chest drain removal with an average expected time of 48 hours up to seven days)
- length of hospital stay(Hospital departure with an expected average time of two weeks to one month)
- duration of intravenous antibiotic therapy(up to the last intravenous antibiotic injection, minimum of 48 hours for a simple pleural effusion and a minimum of 14 days for an empyema with a maximum of one month)
- Duration of fever > 38.5°C(Up to fever resolution, with an average expected time of five days to 14 days)
研究者
研究点 (1)
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