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

NCT01869504 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2017-05-22

No results posted yet for this study

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

Interventions

DEVICE

Balloon-tipped intercostal drain

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

Sponsors & Collaborators

  • Sherwood Forest Hospitals NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Samuel V Kemp, MBBS · Sherwood Forest Hospitals NHS Foundation Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01869504 on ClinicalTrials.gov