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

NCT01869504 | Completed

• 1 other identifier: SFH1
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Pleural Effusion

Keywords

Ballooned intercostal drain; Pleural effusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

Balloon-tipped intercostal drain

EXPERIMENTAL

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

Interventions

Balloon-tipped intercostal drain DEVICE

Ballooned intercostal drain for pleural effusion, inserted using local anaesthetic and ultrasound guidance.

Also known as: Manufactured by Rocket Medical.

Balloon-tipped intercostal drain

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>16 years
• Able to give written informed consent
• Requiring intercostal tube drainage of a pleural effusion for clinical reasons

You may not qualify if:

• Requiring intercostal tube drainage for chest trauma
• Requiring blunt dissection for drain insertion

Sponsors & Collaborators

• Sherwood Forest Hospitals NHS Foundation Trust: lead

Study Sites (1)

King's Mill Hospital

Sutton in Ashfield, Nottinghamshire, NG17 4JL, United Kingdom

Location

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Samuel V Kemp, MBBS

  Sherwood Forest Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2013
• First Posted: June 5, 2013
• Study Start: February 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: May 22, 2017

Record last verified: 2017-05

Locations

GB (1)