Ballooned Intercostal Drain Trial

NCT03000504 | Unknown DMC

• 1 other identifier: 217496
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 3

Brief Summary

This study is designed to assess whether a new type of chest drain reduces the number of drains that fall out of or are accidentally removed from the chest cavity (usually requiring another drain to be inserted), without causing any increase in discomfort or other side-effects.

Conditions

Pleural Effusion; Pneumothorax

Outcome Measures

Primary Outcomes (1)

• The difference in the percentage of accidental removal of ICTs between study arms

  The number of drains prematurely and unintentionally removed from the pleural space

  Up to 1 week dependent upon duration of intercostal drainage

Secondary Outcomes (4)

• The difference in patient reported pain scores, using a visual analogue scale

  At drain insertion, 24hrs post-insertion, 72hrs-post insertion, and at drain removal, usually a maximum of 7 days

• The frequency of balloon rupture

  Up to 1 week dependent upon duration of intercostal drainage

• The difference in duration of drainage between the study arms

  Up to 1 week dependent upon duration of intercostal drainage

• Cost-effectiveness profiles for each intervention

  Up to 1 week dependent upon duration of intercostal drainage

Study Arms (2)

Ballooned intercostal drain

EXPERIMENTAL

Patients will have a Rocket Medical 16F ballooned chest drain inserted as per usual clinical guidelines. No other change to treatment will be made, and the drain is inserted in exactly the same way as a standard drain, using the Seldinger technique.

Device: Ballooned intercostal drain

Standard intercostal drain

ACTIVE COMPARATOR

Patients will have a standard 12F-16F Rocket Medical chest drain inserted as per usual clinical guidelines, using the Seldinger technique.

Device: Ballooned intercostal drain

Interventions

Ballooned intercostal drain DEVICE

Patients will have a Rocket Medical 16F ballooned intercostal drain inserted as per usual clinical guidelines. No other change to treatment will be made, and the drain is inserted in exactly the same way as a standard drain, using the Seldinger technique.

Ballooned intercostal drain; Standard intercostal drain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>16 years
• Able to give written informed consent
• Requiring intercostal tube drainage for clinical reasons

You may not qualify if:

• Inability to provide written informed consent
• Requiring blunt dissection for intercostal tube insertion
• Haemothorax

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead
• Sherwood Forest Hospitals NHS Foundation Trust: collaborator
• Oxford University Hospitals NHS Trust: collaborator

Study Sites (3)

Sherwood Forest Hospitals NHS Foundation Trusty

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

RECRUITING

Oxford Respiratory Trials Unit

Oxford, Oxfordshire, OX3 7LE, United Kingdom

RECRUITING

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pleural Effusion; Pneumothorax

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Samuel V Kemp, MBBS, MD

  Royal Brompton and Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samuel V Kemp, MBBS, MD

CONTACT

+442073518021; s.kemp@rbht.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2016
• First Posted: December 22, 2016
• Study Start: March 7, 2018
• Primary Completion: June 1, 2019
• Study Completion: July 1, 2019
• Last Updated: May 16, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)