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

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.

Study Overview

• Status: Completed
• Conditions: Pleural Effusion
• Intervention / Treatment: Device: Balloon-tipped intercostal drain

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Nottinghamshire
    • Sutton-in-Ashfield, Nottinghamshire, United Kingdom, NG17 4JL
      • King's Mill Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: Balloon-tipped intercostal drain; Ballooned intercostal drain for pleural effusion, inserted using local anaesthetic and ultrasound guidance.; Other Names: Manufactured by Rocket Medical.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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

Collaborators and Investigators

• Sponsor: Sherwood Forest Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Samuel V Kemp, MBBS, Sherwood Forest Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: February 26, 2013
• First Submitted That Met QC Criteria: May 31, 2013
• First Posted (Estimate): June 5, 2013

Study Record Updates

• Last Update Posted (Actual): May 22, 2017
• Last Update Submitted That Met QC Criteria: May 19, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Pleural effusion; Ballooned intercostal drain
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pleural Effusion
• Other Study ID Numbers: SFH1