Ballooned Intercostal Drain Trial

A Randomized, Controlled Trial of the Use of a Dedicated Ballooned Intercostal Tube

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.

Study Overview

• Status: Unknown
• Conditions: Pneumothorax; Pleural Effusion
• Intervention / Treatment: Device: Ballooned intercostal drain

Detailed Description

Chest drains are an essential part of the treatment for patients with fluid or air around the lung, which usually causes breathlessness. Draining the fluid or air relieves symptoms and allows investigations to be carried out that can identify a cause for why the fluid or air is there. Chest drains are difficult to secure in place, and sometimes fall out despite the best possible care. This study tests a modified drain that has a small balloon near the end which, when inflated inside the chest cavity, should make it much harder for the drain to fall out of the chest. This was tested in a small pilot study, with encouraging results. The current study is comparing a group of patients treated with the new ballooned drain against a group treated with the standard drain, with patients equally but randomly allocated to each group. The chest drain has been through rigorous laboratory testing and has been CE marked for human use.

All patients requiring intercostal drainage for clinical reasons will be offered entry into the study, unless, in the view of the treating physician, blunt dissection is required. No other screening assessments will be required, other than the ability to sign the informed consent form.Patients who have provided signed informed consent will then proceed to the study protocol. Patients will be randomised to undergo either standard ICT insertion (usual clinical care) or insertion of the study drain using standard clinical policies and procedures at each participating centre.

Once a patient has been identified for the trial and has signed the informed consent form, baseline details will be entered into a dedicated web-based programme accessible at all sites, and patients will be allocated 1:1 to either usual care or to the study drain.

All subsequent care will be as per best clinical care for all patients in both arms of the study. The only additional assessments over and above usual care will be the collection of pain scores. Pain will be rated by the patients on a visual analogue scale (VAS) on up to 4 occasions - insertion, 24 and 72 hours post insertion, and at drain removal.

• Study Type: Interventional
• Enrollment (Anticipated): 178
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Samuel V Kemp, MBBS, MD; Phone Number: +442073518021; Email: s.kemp@rbht.nhs.uk

Study Locations

• United Kingdom
  • London, United Kingdom, SW3 6NP
    • Recruiting
    • Royal Brompton Hospital
    • Contact: Samuel V Kemp, MBBS MD; Phone Number: +442073518021; Email: s.kemp@rbht.nhs.uk
  • Nottinghamshire
    • Sutton in Ashfield, Nottinghamshire, United Kingdom, NG17 4JL
      • Recruiting
      • Sherwood Forest Hospitals NHS Foundation Trusty
      • Contact: Nicola J Downer, MBBS; Phone Number: +441623622515; Email: nicola.downer@sfh-tr.nhs.uk
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 7LE
      • Recruiting
      • Oxford Respiratory Trials Unit
      • Contact: Najib Rahman, PhD; Phone Number: +441865 225256; Email: najib.rahman@ndm.ox.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age >16 years
2. Able to give written informed consent
3. Requiring intercostal tube drainage for clinical reasons

Exclusion Criteria:

1. Inability to provide written informed consent
2. Requiring blunt dissection for intercostal tube insertion
3. Haemothorax

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ballooned intercostal drain; 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; 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.
Active Comparator: Standard intercostal drain; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Royal Brompton & Harefield NHS Foundation Trust
• Collaborators: Oxford University Hospitals NHS Trust; Sherwood Forest Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Samuel V Kemp, MBBS, MD, Royal Brompton and Harefield NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2018
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: November 25, 2016
• First Submitted That Met QC Criteria: December 21, 2016
• First Posted (Estimate): December 22, 2016

Study Record Updates

• Last Update Posted (Actual): May 16, 2018
• Last Update Submitted That Met QC Criteria: May 10, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pneumothorax; Pleural Effusion
• Other Study ID Numbers: 217496

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No