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临床试验/NCT01869504
NCT01869504已完成不适用

A Feasibility and Safety Study of the Use of a Dedicated Ballooned Intercostal Drain

Sherwood Forest Hospitals NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2014年2月1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
入组人数
19
试验地点
2
主要终点
The percentage of intercostal drains requiring re-siting

研究概览

简要总结

Drainage of air and fluid from the chest cavity using plastic tubes (chest drains) is an essential tool in Chest Medicine. A common complication of drain insertion is accidental removal of the drain, usually as a result of inadequate securing techniques, with rates of up to 1 in 5 reported. This often results in the need for further procedures (including drain re-siting), with associated additional risk to the patient and an increase in health care costs. One suggested method to reduce premature drain removal is to use chest drains with ballooned tips, much like a bladder catheter. These would provide a physical obstruction inside the chest cavity at the insertion site, whilst being easy to use as stitching or extensive taping may not be required.

The investigators propose a trial of a dedicated ballooned chest drain to investigate whether a reduction in drain re-siting rates can be achieved. Pain scores will also be assessed during this trial to ensure that irritation of the lining of the lung or chest wall by the balloon is not excessive.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >16 years
  • Able to give written informed consent
  • Requiring intercostal tube drainage of a pleural effusion for clinical reasons

排除标准

  • Requiring intercostal tube drainage for chest trauma
  • Requiring blunt dissection for drain insertion

结局指标

主要结局

The percentage of intercostal drains requiring re-siting

时间窗: 7 days

It is likely that most if not all of the drains will have been removed by this time owing to resolution of the effusion, but the time period of 7 days has been selected to allow maximum data capture.

次要结局

  • Patient reported pain scores, using a visual analogue scale(At 24 hours, 72 hours, and at drain removal, an expected average of 5 days)
  • The frequency of balloon rupture(7 days)

研究者

发起方
Sherwood Forest Hospitals NHS Foundation Trust
申办方类型
Other
责任方
Sponsor

研究点 (2)

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