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

NCT ID: NCT01869504

Last Updated: 2017-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2014-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Balloon-tipped intercostal drain

Intervention Type: DEVICE

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

Interventions

Balloon-tipped intercostal drain

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

Intervention Type: DEVICE

Other Intervention Names

Manufactured by Rocket Medical.

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sherwood Forest Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samuel V Kemp, MBBS

Role: PRINCIPAL_INVESTIGATOR

Sherwood Forest Hospitals NHS Foundation Trust

Locations

King's Mill Hospital

Sutton in Ashfield, Nottinghamshire, United Kingdom

Countries

United Kingdom

Other Identifiers

SFH1

Identifier Type: -

Identifier Source: org_study_id