Condition category
Respiratory
Date applied
03/01/2018
Date assigned
11/01/2018
Last edited
11/01/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The use of a tube inserted between the ribs (intercostal drain) to remove air or fluid from around the lung is an essential tool in the management of respiratory patients. A common complication of drain insertion is accidental removal of the drain, usually as a result of inadequate securing techniques. This often results in the need for further medical or surgical procedures (including drain re-siting), with associated additional risk to the patient and an increase in healthcare costs. One suggested method to reduce premature drain removal is to use intercostal drains with ballooned tips. The balloon would then provide a relatively harmless physical obstruction to the drain insertion site. A small study of the new drains suggested that there was a reduced need for further procedures without causing any additional discomfort or problems. The aim of this study is to find out whether the use of a dedicated ballooned intercostal drain leads to a reduction in drain re-siting rates.

Who can participate?
Patients aged 18 or over who require intercostal tube drainage

What does the study involve?
Participants are randomly allocated to either the new treatment (dedicated ballooned intercostal drain) or to standard care (conventional chest drain). The rates of unintentional/accidental chest drain displacement in the two groups are compared. Pain is also assessed to ensure that irritation of the lining of the lung and chest wall is not prohibitive.

What are the possible benefits and risks of participating?
It is hoped that the new chest drain is more secure and less likely to become dislodged or fall out, which means that the treatment may be more effective and may reduce the chances of needing another chest drain inserting. It is not anticipated that there will be any specific risks or disadvantages over standard medical care, other than the possibility that the balloon on the end of the drain could cause some irritation to the lining of the lung and chest wall. This may cause some discomfort. Risks associated with putting in any chest drain include:
1. Infection - as with any invasive procedure, there is a risk of infection. Using sterile procedures helps reduce this risk.
2. Bleeding - a very small amount of bleeding can occur if a blood vessel is damaged when the chest tube is inserted.
3. Poor tube placement - the chest drain can be placed too far inside the pleural space, not far enough, or can fall out.
Serious complications are rare. However, they can include: bleeding into the chest cavity, injury to the lung or diaphragm, and pneumothorax (punctured lung). Participants have at least one chest x-ray after the drain is inserted and another before the drain is removed, but these would be needed whether they are in the study or not. A chest x-ray involves a very small amount of ionising radiation which is equivalent to 4 days of natural background radiation. Ionising radiation can cause cell damage that may, after many years or decades, turn cancerous. The chance of this happening is less than 0.001%, and is the same whether they take part in this study or not.

Where is the study run from?
1. Royal Brompton Hospital (UK)
2. King’s Mill Hospital (UK)
3. John Radcliffe Hospital (UK)
4. Churchill Hospital (UK)
5. Southmead Hospital (UK)
6. Musgrove Hospital (UK)
7. Wythenshawe Hospital (UK)
8. Norwich and Norfolk NHS Foundation Trust (UK)
9. Plymouth Hospitals NHS Trust (UK)
10. Royal Stoke University Hospital (UK)
11. Glenfield Hospital (UK)
12. Victoria Hospital (UK)

When is the study starting and how long is it expected to run for?
September 2017 to January 2020

Who is funding the study?
Rocket Medical PLC (UK)

Who is the main contact?
Dr Rachel Mercer

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rachel Mercer

ORCID ID

http://orcid.org/0000-0003-3645-3151

Contact details

Oxford Respiratory Trials Unit
Churchill Hospital
Old Road
Oxford
OX3 8HZ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

36669

Study information

Scientific title

A randomised controlled trial of the use of a dedicated ballooned intercostal drain

Acronym

BASIC

Study hypothesis

The use of a tube inserted between the ribs (intercostal drain) to remove air or fluid from around the lung is an essential tool in the management of respiratory patients. A common complication of drain insertion is accidental removal of the drain, usually as a result of inadequate securing techniques. This often results in the need for further medical or surgical 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 intercostal drains with ballooned tips. The balloon would then provide a relatively atraumatic physical obstruction to the drain insertion site.

A small trial of the new drains suggested that there was a reduced need for further procedures without causing any additional discomfort or problems. The trialists propose a randomised controlled trial (i.e. patients are randomly assigned to either the new treatment or to standard care) of a dedicated ballooned intercostal 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 and chest wall is not prohibitive.

Ethics approval

South Central Oxford B, 15/12/2017, ref: 17/SC/0607

Study design

Randomised; Interventional; Design type: Treatment, Device

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files

Condition

Specialty: Respiratory disorders, Primary sub-specialty: Respiratory disorders; UKCRC code/ Disease: Respiratory/ Other diseases of pleura

Intervention

Randomisation will be via an online platform and will be 1:1, minimised by site and underlying aetiology. The standard arm will be insertion of a conventional chest drain as per standard British Thoracic Society Guidelines. The Interventional arm will have a chest drain with a balloon on the shaft which will be inflated once in the pleural cavity. Both arms will be monitored for unintentional drain displacement, timing of drain removal, pain and any complications. The time that the drain is in situ is variable but is usually under 1 week. All patients will be followed up at 30 days after drain removal.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Unintentional/accidental chest drain displacement rate (UACDR); Timepoint(s): Within 30 days

Secondary outcome measures

1. Pain, measured using the visual analogue scale (VAS) at baseline then twice daily for the first 5 days or until the drain has been removed, whichever is sooner
2. Complications listed on the CRFs and to be recorded daily on the CRFs
3. Length of stay, further pleural procedures, number of days any chest drain in situ, number of radiological investigations, consequences of drain displacement, documented on CRFs up to 30 days after drain removal

Overall trial start date

06/09/2017

Overall trial end date

15/01/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Age 18 years or over
2. Able to give written informed consent
3. Requiring intercostal tube drainage for clinical reasons

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 136; UK Sample Size: 136

Participant exclusion criteria

1. Inability to provide written informed consent
2. Requiring a large bore drain according to local PI or delegated person’s clinical judgement
3. Frank haemothorax (requiring a large bore chest drain in view of the local PI or delegated person)
4. Pleural space (known prior to intervention) to be too small to place either standard or interventional drain according to local PI or delegated person
5. Drain planned to be in situ for less than 24 hours
6. Any contraindication to chest drain insertion (such as uncorrected clotting abnormality)
7. Any patient in acute pain or with an emergency presentation where consideration of the study would inappropriately delay patient care

Recruitment start date

15/02/2018

Recruitment end date

15/08/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Brompton Hospital
Sydney Street
London
SW3 6NP

Trial participating centre

King’s Mill Hospital
Mansfield Road
Sutton-in-Ashfield
NG17 4JL

Trial participating centre

Oxford University Hospitals NHS Foundation Trust
John Radcliffe Hospital (lead site, also Churchill Hospital) Headley Way
Oxford
OX3 9DU

Trial participating centre

North Bristol NHS Trust
Southmead Hospital Westbury-on-Trym
Bristol
BS10 5NB

Trial participating centre

Taunton and Somerset NHS Foundation Trust
Musgrove Hospital
Taunton
TA1 5DA

Trial participating centre

University Hospital of South Manchester NHS Foundation Trust (Wythenshawe Hospital)
Southmoor Road Wythenshawe
Manchester
M23 9LT

Trial participating centre

Norwich and Norfolk NHS Foundation Trust
Colney Lane
Norwich
NR4 7UY

Trial participating centre

Plymouth Hospitals NHS Trust
Derriford Road Crownhill
Plymouth
PL6 8DH

Trial participating centre

University Hospitals of North Midlands NHS Trust (Royal Stoke University Hospital)
Newcastle Road
Stoke-On-Trent
ST4 6QG

Trial participating centre

University Hospitals of Leicester NHS Trust (Glenfield Hospital)
Gwendolen Road
Leicester
LE5 4QF

Trial participating centre

Blackpool Teaching Hospitals NHS Foundation Trust
Victoria Hospital Whinney Heys Road
Blackpool
FY3 8NR

Sponsor information

Organisation

Royal Brompton & Harefield NHS Foundation Trust

Sponsor details

c/o Patrik Pettersson
Non-Commercial Research Business Manager
Royal Brompton Hospital
Sydney Street
London
SW3 6NP
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Rocket Medical PLC

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The protocol will be submitted for publication. The aim is to publish the results in national and international journals within a year of complete data collection.

IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

15/01/2021

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes