Ballooned Intercostal Drain Trial

Pleural Effusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03000504
• Other study ID #: 217496
• Status: Recruiting
• Phase: N/A
• Start date: March 7, 2018
• Est. completion date: July 2019

Study information

• Verified date: May 2018
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: Samuel V Kemp, MBBS, MD
• Phone: +442073518021
• Email: s.kemp[@]rbht.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 178
• Est. completion date: July 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pleural Effusion
• Pneumothorax

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Royal Brompton Hospital	London
United Kingdom	Oxford Respiratory Trials Unit	Oxford	Oxfordshire
United Kingdom	Sherwood Forest Hospitals NHS Foundation Trusty	Sutton in Ashfield	Nottinghamshire

Sponsors (3)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust	Oxford University Hospitals NHS Trust, Sherwood Forest Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	The frequency of balloon rupture		Up to 1 week dependent upon duration of intercostal drainage
Secondary	The difference in duration of drainage between the study arms		Up to 1 week dependent upon duration of intercostal drainage
Secondary	Cost-effectiveness profiles for each intervention		Up to 1 week dependent upon duration of intercostal drainage