NCT01869504

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Sherwood Forest Hospitals NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pleural Effusion

Interventions

Type	Name	Description
DEVICE	Balloon-tipped intercostal drain	Ballooned intercostal drain for pleural effusion, inserted using local anaesthetic and ultrasound guidance.

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2013-06-05
• Last updated: 2017-05-22

Locations

1 site across 1 country: United Kingdom