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Completed

NCT Number: NCT01869504

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King's Mill Hospital

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Balloon-tipped intercostal drain

Device

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

Other names: Manufactured by Rocket Medical.

Primary outcomes

  1. The percentage of intercostal drains requiring re-siting

    Time frame: 7 days

    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 outcomes

  1. 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

  2. The frequency of balloon rupture

    Time frame: 7 days

    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.

Sponsors and collaborators

Lead sponsor

Sherwood Forest Hospitals NHS Foundation Trust

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 5, 2013
Registry last updated
May 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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