Ballooned Intercostal Drain Trial

NCT ID: NCT03000504

Last Updated: 2018-05-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-07
• Study Completion Date: 2019-07-31

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.

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.

Conditions

Pleural Effusion; Pneumothorax

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Ballooned intercostal drain

Intervention Type: 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.

Standard intercostal drain

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

Group Type: ACTIVE_COMPARATOR

Ballooned intercostal drain

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sherwood Forest Hospitals NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Oxford University Hospitals NHS Trust

OTHER

Sponsor Role: collaborator

Royal Brompton & Harefield NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samuel V Kemp, MBBS, MD

Role: PRINCIPAL_INVESTIGATOR

Royal Brompton and Harefield NHS Foundation Trust

Locations

Sherwood Forest Hospitals NHS Foundation Trusty

Sutton in Ashfield, Nottinghamshire, United Kingdom

Site Status: RECRUITING

Oxford Respiratory Trials Unit

Oxford, Oxfordshire, United Kingdom

Site Status: RECRUITING

Royal Brompton Hospital

London, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Samuel V Kemp, MBBS, MD

Role: CONTACT

s.kemp@rbht.nhs.uk

+442073518021

Facility Contacts

Nicola J Downer, MBBS

Role: primary

nicola.downer@sfh-tr.nhs.uk

+441623622515

Najib Rahman, PhD

Role: primary

najib.rahman@ndm.ox.ac.uk

+441865 225256

Samuel V Kemp, MBBS MD

Role: primary

s.kemp@rbht.nhs.uk

+442073518021

Other Identifiers

217496

Identifier Type: -

Identifier Source: org_study_id