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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Sherwood Forest Hospitals NHS Foundation Trust
Sponsor:
Information provided by (Responsible Party):
Sherwood Forest Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01869504
First received: February 26, 2013
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Pleural Effusion
Device: Balloon-tipped intercostal drain

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Feasibility and Safety Study of the Use of a Dedicated Ballooned Intercostal Drain

Further study details as provided by Sherwood Forest Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • The percentage of intercostal drains requiring re-siting [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: At 24 hours, 72 hours, and at drain removal, an expected average of 5 days ] [ Designated as safety issue: No ]
  • The frequency of balloon rupture [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 20
Study Start Date: February 2014
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Manufactured by Rocket Medical.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01869504

Contacts
Contact: Samuel V Kemp, MBBS 01623622515 ext 6264 samuel.kemp@sfh-tr.nhs.uk
Contact: Samantha Jones, BA 01623622515 ext 3313 samantha.jones@sfh-tr.nhs.uk

Locations
United Kingdom
King's Mill Hospital Recruiting
Sutton-in-Ashfield, Nottinghamshire, United Kingdom, NG17 4JL
Contact: Samantha Jones    01623622515 ext 3313    samantha.jones@sfh-tr.nhs.uk   
Principal Investigator: Samuel V Kemp, MBBS         
Sponsors and Collaborators
Sherwood Forest Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Samuel V Kemp, MBBS Sherwood Forest Hospitals NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Sherwood Forest Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01869504     History of Changes
Other Study ID Numbers: SFH1
Study First Received: February 26, 2013
Last Updated: February 5, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Sherwood Forest Hospitals NHS Foundation Trust:
Ballooned intercostal drain
Pleural effusion

Additional relevant MeSH terms:
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014