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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Emma Tucker
+44 (0)117 414 8114
emma.tucker2@nbt.nhs.uk


Dr Hugh Welch
+44 (0)117 414 8041
hugh.welch@nbt.nhs.uk


Prof Nick Maskell
+44 (0)117 414 8114
nick.maskell@bristol.ac.uk


Study Location:

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Be Part of Research - Trial Details - Comparing methods to manage recurrent fluid build up around the lung caused by problems with the heart - what is the best way to measure this and which method do patients prefer?
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Comparing methods to manage recurrent fluid build up around the lung caused by problems with the heart - what is the best way to measure this and which method do patients prefer?

Not Recruiting

Open to: All Genders

Age: Adult

London Stoke-on-trent Oxford Plymouth Leicester Newport London Manchester Hartlepool North Shields Bristol Macclesfield

Medical Conditions

Recurrent pleural effusion secondary to heart failure

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This study is part of an effort to determine the best way of managing recurrent fluid build-up around the lungs (a pleural effusion) caused by problems with the heart that cannot be managed with medications alone. The current method for managing this fluid build-up is to remove the fluid using a needle and syringe. This procedure is known as a therapeutic aspiration. Therapeutic aspirations are generally performed as often as indicated by a patient’s symptoms. An alternative method is to insert an indwelling pleural catheter (IPC) which is a small, soft rubber tube that is placed into the chest wall. This remains in for as long as required and allows the fluid to be drained regularly in the patient’s home without the use of any needles. In this study medical-grade talc will be given once only through the IPC to attempt to ‘dry up’ or stop the fluid coming back. This would therefore allow removal of the IPC. The aim of this study is to compare these two methods and gain some feedback on patient experiences with the use of an IPC to inform future similar trials.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

19 Jan 2022 12 Jul 2024

The study involves five hospital visits:
Visit 1: an initial assessment to discuss the study, check that the patient is suitable and determine which method of managing fluid build up they will receive.
Visit 2: patients would have either an IPC inserted or a therapeutic aspiration depending on which method has been randomly allocated.
Visit 2b: for those with an IPC only - to have medical talc inserted into their IPC 7 days after it has been inserted and to have a quick check up the following day
Visit 3: Week 2 follow-up appointment
Visit 4: Week 4 follow-up appointment
Visit 5: Week 12 follow-up appointment
At all visits chest x-rays, ultrasounds and blood tests will be performed, similar to a usual hospital follow up. Additional health questionnaires will also be completed. Between visits participants will have fluid drained off regularly if they have an IPC inserted, or only when needed if they have been allocated to the therapeutic aspiration method. Participants will also be asked to keep a diary of any fluid removed and how much breathlessness or chest pain they are experiencing.


Patients with recurrent fluid build-up around the lungs (a pleural effusion) caused by problems with the heart that cannot be managed with medications alone and who are suitable to have an IPC

You can take part if:



You may not be able to take part if:


1. Age <18 years2. Known pleural malignancy3. Pregnancy, lactation or intention to become pregnant4. Absolute contraindication to IPC insertion or therapeutic aspiration of pleural fluid5. Previous attempts at ipsilateral pleurodesis6. Evidence of extensive lung entrapment on chest x-ray or CT, or significant fluid loculation on ultrasound scan, to a level which would normally be a contraindication to attempted talc pleurodesis or IPC insertion.7. Inability to give informed consent8. Patient has no access to a telephone


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Royal Free Hospital
    Pond Street
    London
    NW3 2QG
  • Royal Stoke University Hospital
    Newcastle Road
    Stoke-on-trent
    ST4 6QG
  • John Radcliffe Hospital
    Headley Way Headington
    Oxford
    OX3 9DU
  • Derriford Hospital
    Derriford Road Derriford
    Plymouth
    PL6 8DH
  • Leicester Royal Infirmary
    Infirmary Square
    Leicester
    LE1 5WW
  • St Cadoc's Hospital
    Lodge Road Caerleon
    Newport
    NP18 3XQ
  • St Thomas' Hospital
    Westminster Bridge Road
    London
    SE1 7EH
  • Manchester Royal Infirmary
    Oxford Road
    Manchester
    M13 9WL
  • University Hospital of Hartlepool
    Holdforth Road
    Hartlepool
    TS24 9AH
  • North Tyneside General Hospital
    Rake Lane
    North Shields
    NE29 8NH
  • Southmead Hospital
    Clinical Research Centre - Respiratory North Bristol NHS Trust
    Bristol
    BS10 5NB
  • Macclesfield General Hospital
    Ground Floor Silk House Victoria Road
    Macclesfield
    SK10 3BL

It is hoped that every patient will gain benefit from fluid being removed whether it is through an IPC or by therapeutic aspiration. Participation in this trial will contribute to the understanding and development of new and better ways to manage pleural effusions due to heart failure, which will hopefully benefit patients in the future. Therapeutic aspirations are the current standard method for removing fluid build-up around the lung but there is a greater risk of infection as more procedures are carried out. This is one of the reasons for conducting this research to look for an alternative method for managing recurrent fluid build-up. During or at the end of drainage some patients can experience coughing, or mild chest discomfort or pain, but this should settle shortly after the drainage is stopped and is completely normal. With each therapeutic aspiration there is a very small risk of infection entering during the procedure and the risk is reduced by using sterile techniques.
Neither of the alternative treatments in this trial are new, with both talc and indwelling pleural catheters having been shown to be safe and well-tolerated. Individually they can both cause minor side effects which are detailed below. One of the aims of this study is to determine what side effects, if any, there are from using talc and IPCs together. In order to do this the participants will be monitored closely throughout the study period.
Similar to a therapeutic aspiration, during or at the end of IPC drainage some patients can experience coughing, or mild chest discomfort or pain, but this should settle shortly after the drainage is stopped and is completely normal. There is a very small risk of infection entering both during the procedure and afterwards, when at home. This risk is reduced by using sterile techniques whenever the drain is used.
Talc is generally very safe, but patients can sometimes experience pain in the chest around the time it is inserted. They will usually be given painkillers before the procedure and be given local anaesthetic along with the talc.

Dr Emma Tucker
+44 (0)117 414 8114
emma.tucker2@nbt.nhs.uk


Prof Nick Maskell
+44 (0)117 414 8114
nick.maskell@bristol.ac.uk


Dr Hugh Welch
+44 (0)117 414 8041
hugh.welch@nbt.nhs.uk



The study is sponsored by North Bristol NHS Trust and funded by BD.



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Read full details for Trial ID: ISRCTN10499680

Or CPMS 49844

Last updated 23 July 2024

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