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

Primary Purpose

Pleural Effusion

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Balloon-tipped intercostal drain
Sponsored by
Sherwood Forest Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pleural Effusion focused on measuring Ballooned intercostal drain, Pleural effusion

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • King's Mill Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Balloon-tipped intercostal drain

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Patient reported pain scores, using a visual analogue scale
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.

Full Information

First Posted
February 26, 2013
Last Updated
May 19, 2017
Sponsor
Sherwood Forest Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01869504
Brief Title
A Feasibility and Safety Study of the Use of a Dedicated Ballooned Intercostal Drain
Official Title
A Feasibility and Safety Study of the Use of a Dedicated Ballooned Intercostal Drain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sherwood Forest Hospitals NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Effusion
Keywords
Ballooned intercostal drain, Pleural effusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Balloon-tipped intercostal drain
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Balloon-tipped intercostal drain
Other Intervention Name(s)
Manufactured by Rocket Medical.
Intervention Description
Ballooned intercostal drain for pleural effusion, inserted using local anaesthetic and ultrasound guidance.
Primary Outcome Measure Information:
Title
The percentage of intercostal drains requiring re-siting
Description
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.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Patient reported pain scores, using a visual analogue scale
Time Frame
At 24 hours, 72 hours, and at drain removal, an expected average of 5 days
Title
The frequency of balloon rupture
Description
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.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel V Kemp, MBBS
Organizational Affiliation
Sherwood Forest Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
King's Mill Hospital
City
Sutton-in-Ashfield
State/Province
Nottinghamshire
ZIP/Postal Code
NG17 4JL
Country
United Kingdom

12. IPD Sharing Statement

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

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