A Feasibility and Safety Study of the Use of a Dedicated Ballooned Intercostal Drain
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|ClinicalTrials.gov Identifier: NCT01869504|
Recruitment Status : Completed
First Posted : June 5, 2013
Last Update Posted : May 22, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Pleural Effusion||Device: Balloon-tipped intercostal drain||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Feasibility and Safety Study of the Use of a Dedicated Ballooned Intercostal Drain|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
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.
- The percentage of intercostal drains requiring re-siting [ Time Frame: 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.
- 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 ]
- The frequency of balloon rupture [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01869504
|King's Mill Hospital|
|Sutton-in-Ashfield, Nottinghamshire, United Kingdom, NG17 4JL|
|Principal Investigator:||Samuel V Kemp, MBBS||Sherwood Forest Hospitals NHS Foundation Trust|