A Feasibility and Safety Study of the Use of a Dedicated Ballooned Intercostal Drain
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Feasibility and Safety Study of the Use of a Dedicated Ballooned Intercostal Drain|
- The percentage of intercostal drains requiring re-siting [ Time Frame: 7 days ] [ Designated as safety issue: No ]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.
- Patient reported pain scores, using a visual analogue scale [ Time Frame: At 24 hours, 72 hours, and at drain removal, an expected average of 5 days ] [ Designated as safety issue: No ]
- The frequency of balloon rupture [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||February 2014|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Experimental: 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.
Device: Balloon-tipped intercostal drain
Ballooned intercostal drain for pleural effusion, inserted using local anaesthetic and ultrasound guidance.
Other Name: Manufactured by Rocket Medical.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01869504
|Contact: Samuel V Kemp, MBBS||01623622515 ext firstname.lastname@example.org|
|Contact: Samantha Jones, BA||01623622515 ext email@example.com|
|King's Mill Hospital||Recruiting|
|Sutton-in-Ashfield, Nottinghamshire, United Kingdom, NG17 4JL|
|Contact: Samantha Jones 01623622515 ext 3313 firstname.lastname@example.org|
|Principal Investigator: Samuel V Kemp, MBBS|
|Principal Investigator:||Samuel V Kemp, MBBS||Sherwood Forest Hospitals NHS Foundation Trust|