A randomised controlled trial of the use of a dedicated ballooned intercostal drain
| ISRCTN | ISRCTN37304337 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37304337 |
| Secondary identifying numbers | 36669 |
- Submission date
- 03/01/2018
- Registration date
- 11/01/2018
- Last edited
- 28/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
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 July 2020
Who is funding the study?
Rocket Medical PLC (UK)
Who is the main contact?
Dr Rachel Mercer
Contact information
Scientific
Oxford Respiratory Trials Unit
Churchill Hospital
Old Road
Oxford
OX3 8HZ
United Kingdom
 ORCID ID |
0000-0003-3645-3151 |
|---|
Study information
| Study design | Randomised; Interventional; Design type: Treatment, Device |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN37304337_PIS_V2.0_24Nov2017.doc |
| Scientific title | A randomised controlled trial of the use of a dedicated ballooned intercostal drain |
| Study 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(s) | South Central Oxford B, 15/12/2017, ref: 17/SC/0607 |
| Condition | Intercostal drain |
| 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 |
| 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 study start date | 06/09/2017 |
| Overall study end date | 20/12/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 267; UK Sample Size: 267 |
| Total final enrolment | 267 |
| 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 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 | 13/11/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
London
SW3 6NP
United Kingdom
Sutton-in-Ashfield
NG17 4JL
United Kingdom
Headley Way
Oxford
OX3 9DU
United Kingdom
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
Taunton
TA1 5DA
United Kingdom
Wythenshawe
Manchester
M23 9LT
United Kingdom
Norwich
NR4 7UY
United Kingdom
Crownhill
Plymouth
PL6 8DH
United Kingdom
Stoke-On-Trent
ST4 6QG
United Kingdom
Leicester
LE5 4QF
United Kingdom
Whinney Heys Road
Blackpool
FY3 8NR
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Patrik Pettersson
Non-Commercial Research Business Manager
Royal Brompton Hospital
Sydney Street
London
SW3 6NP
England
United Kingdom
"ROR" |
https://ror.org/02218z997 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 20/12/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| 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 plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V2.0 | 24/11/2017 | 11/01/2018 | No | Yes |
| Abstract results | 28/10/2020 | 04/03/2022 | No | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol file | version 7.0 | 03/04/2019 | 28/02/2024 | No | No |
| Results article | 21/07/2022 | 28/02/2024 | Yes | No |
Additional files
- ISRCTN37304337_PIS_V2.0_24Nov2017.doc
- Uploaded 11/01/2018
- ISRCTN37304337_Protocol_V7.0_03April2019.pdf
Editorial Notes
28/02/2024: Publication reference and protocol (not peer reviewed) file added.
04/03/2022: Publication reference added.
29/01/2020: The following changes have been made:
1. The recruitment end date has been changed from 31/12/2019 to 13/11/2019.
2. The overall trial end date has been changed from 15/07/2020 to 20/12/2019.
3. The intention to publish date has been changed from 15/07/2021to 20/12/2020.
4. The total final enrolment number has been added.
10/09/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 15/08/2019 to 31/12/2019.
2. The overall trial end date was changed from 15/01/2020 to 15/07/2020.
3. The intention to publish date was changed from 15/01/2021 to 15/07/2021.
4. The target number of participants was changed from 136 to 267.
29/03/2019: The condition has been changed from "Specialty: Respiratory disorders, Primary sub-specialty: Respiratory disorders; UKCRC code/ Disease: Respiratory/ Other diseases of pleura" to "Intercostal drain" following a request from the NIHR.
