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

Pleural Effusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01869504
• Other study ID #: SFH1
• Status: Completed
• Phase: N/A
• First received: February 26, 2013
• Last updated: May 19, 2017
• Start date: February 2014
• Est. completion date: June 2014

Study information

• Verified date: May 2017
• Source: Sherwood Forest Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pleural Effusion

Intervention

Device:
• Balloon-tipped intercostal drain
Ballooned intercostal drain for pleural effusion, inserted using local anaesthetic and ultrasound guidance.

Locations

Country	Name	City	State
United Kingdom	King's Mill Hospital	Sutton-in-Ashfield	Nottinghamshire

Sponsors (1)

Lead Sponsor	Collaborator
Sherwood Forest Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of intercostal drains requiring re-siting	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.	7 days
Secondary	Patient reported pain scores, using a visual analogue scale		At 24 hours, 72 hours, and at drain removal, an expected average of 5 days
Secondary	The frequency of balloon rupture	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.	7 days