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临床试验/NCT05180955
NCT05180955已完成不适用

The Role of Clamping Before Removal of a Pneumothorax Drain Connected to a Digital Drainage System.

Isala2 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2022年9月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Isala
入组人数
92
试验地点
2
主要终点
Recurrent pneumothorax after chest tube removal

研究概览

简要总结

The study will be conducted as a, prospective, open label, non-inferiority, randomized controlled trial. In the intervention group; chest tube removal will be determined by air flow criteria as indicated by the digital drainage system data. In the control group removal will be determined by the same criteria of the digital drainage system but before removal, a chest tube clamping test will be performed. Primary outcome measure: recurrent pneumothorax after chest tube removal requiring chest tube reinsertion

详细描述

Determining and timing of chest tube removal has been a continuous topic of debate amongst both surgeons and pulmonologist. It is plausible that provocative clamping tests are no longer necessary when a digital continuous recording drainage device is used that demonstrates the absence of (intermittent) air leak. However, clamping trials are still performed in clinical care, it is an expert opinion's policy prompted by fear of recurrent pneumothorax and no comparative studies exist. We hypothesize that chest tube removal exclusively based on digital drainage system data is as safe as adding a clamping test before removal in patients treated for pneumothorax or after lung surgery.

The study will be conducted as a, prospective, open label, non-inferiority, randomized controlled trial. In the intervention group; chest tube removal will be determined by air flow criteria as indicated by the digital drainage system data. In the control group removal will be determined by the same criteria of the digital drainage system but before removal, a chest tube clamping test will be performed.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Digital chest tube drainage system
  • Pneumothorax (primary, secondary, pulmonary surgery)

排除标准

  • Pleural effusion as primary indication for chest tube placement.
  • Suspected chest tube malfunction (e.g., leaking, occlusion, malposition)
  • Intubated during chest tube removal

结局指标

主要结局

Recurrent pneumothorax after chest tube removal

时间窗: 0-24 hours after drain removal

number of patients requiring chest tube reinsertion within 24 hours after chest tube removal for recurrent pneumothorax

次要结局

未报告次要终点

研究者

发起方
Isala
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wytze de Boer

MD

Isala

研究点 (2)

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