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

Not Applicable

Completed

• Conditions: Pleural Effusion
• Interventions: Device: Balloon-tipped intercostal drain

• Registration Number: NCT01869504
• Lead Sponsor: Sherwood Forest Hospitals NHS Foundation Trust

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-02-26
• Study First Submitted QC: 2013-05-31
• Study First Posted: 2013-06-05
• Study Start: 2014-02
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-19
• Last Update Posted: 2017-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Balloon-tipped intercostal drain	Balloon-tipped intercostal drain	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.

Primary Outcome Measures

Name	Time	Method
The percentage of intercostal drains requiring re-siting	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.

Secondary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

King's Mill Hospital; 🇬🇧 Sutton-in-Ashfield, Nottinghamshire, United Kingdom