King's Mill Hospital
Sutton in Ashfield, Nottinghamshire, NG17 4JL, United Kingdom
NCT Number: NCT01869504
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.
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Notify Me16 year and older
All sexes
Interventional
Not applicable
Sutton in Ashfield, Nottinghamshire, NG17 4JL, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ballooned intercostal drain for pleural effusion, inserted using local anaesthetic and ultrasound guidance.
Other names: Manufactured by Rocket Medical.
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.
Time frame: At 24 hours, 72 hours, and at drain removal, an expected average of 5 days
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.
Sherwood Forest Hospitals NHS Foundation Trust
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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