COSINE

  • Research type

    Research Study

  • Full title

    Continuation Of a Study to Investigate the effect of thoracocentesis on Neural respiratory drive in pleural Effusion

  • IRAS ID

    322762

  • Contact name

    Patrick Murphy

  • Contact email

    patrick.murphy@gstt.nhs.uk

  • Sponsor organisation

    Guy's & St Thomas' NHS Foundation Trust

  • Clinicaltrials.gov Identifier

    NCT05945043

  • Duration of Study in the UK

    1 years, 6 months, 0 days

  • Research summary

    The build up of fluid around the lungs (also known as pleural effusion) is very common. It is caused by multiple medical conditions and frequently leads to breathlessness. The aim of treatment is to improve breathlessness and we do this by draining off the fluid. However, how pleural effusions cause breathlessness is not well understood. Some patients are very breathless with a small amount of fluid, others can have large amounts of fluid but little breathlessness. Currently there is no way of predicting who will benefit from fluid drainage or not. The only way to find out is with a trial of drainage. However, 1 in 4 patients undergoing this trial of treatment will not experience any improvement in their breathlessness but will be exposed to the risks of the procedure such as pain, infection, and bleeding.

    The COSINE study aims to improve our understanding of the relationship between pleural effusions and breathlessness.

    This study will involve 124 adult patients who are breathlessness with pleural effusions. They will be recruited from a single UK centre over an 18-month period. When the patients first come to have their fluid drained, we will record information about them and their disease. We will take measurements of their breathlessness, their breathing muscles, and the electrical activity from the brain to those muscles. These will be taken at the start and end of drainage, as well as 1 day and 7 days after. We will use this information to look for links between the effect of pleural effusions and its removal on the electrical activities of the breathing muscles and patients’ breathlessness. We hope with greater understanding of this, we will be able to predict which patients will most likely benefit from fluid removal and improve their care going forwards.

  • REC name

    Yorkshire & The Humber - Leeds West Research Ethics Committee

  • REC reference

    23/YH/0219

  • Date of REC Opinion

    5 Oct 2023

  • REC opinion

    Favourable Opinion