Pleural Effusion
Conditions
Keywords
Ballooned intercostal drain, Pleural effusion
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.
Interventions
DEVICEBalloon-tipped intercostal drain
Ballooned intercostal drain for pleural effusion, inserted using local anaesthetic and ultrasound guidance.
Sponsors
Sherwood Forest Hospitals NHS Foundation Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United Kingdom
Outcome results
None listed