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

Sherwood Forest Hospitals NHS Foundation Trust

Status: Completed

Conditions: Pleural Effusion

Treatments: Device: Balloon-tipped intercostal drain

Study type: Interventional

Funder types: Other

Identifiers

NCT01869504

SFH1

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Balloon-tipped intercostal drain

Experimental group

Description:

Subjects who have given written informed consent and who fulfill the inclusion and exclusion criteria will proceed to have the study drain inserted at the earliest opportunity as per standard hospital protocols using local anaesthetic, and conscious sedation where appropriate. All other aspects of their treatment will be identical to usual clinical care, including chest drain checks and fluid drainage strategies.

Treatment:

Device: Balloon-tipped intercostal drain