Steven P Walker1, Oliver Bintcliffe2, Emma Keenan3, Louise Stadon3, Matthew Evison4, Mohammed Haris5, Thapas Nagarajan6, Alex West7, Alina Ionescu8, Benjamin Prudon9, Anur Guhan10, Rehan Mustafa11, Jurgen Herre12, David Arnold3, Rahul Bhatnagar3, Brennan Kahan13, Robert F Miller14, Najib M Rahman15, Nick A Maskell3. 1. Academic Respiratory Unit, Bristol, UK steven.walker@nbt.nhs.uk. 2. Gloucestershire Royal Hospital, Gloucester, UK. 3. Academic Respiratory Unit, Bristol, UK. 4. Wythenshawe Hospital, Manchester, UK. 5. Royal Stoke University Hospital, Stoke, UK. 6. Macclesfield General Hospital, East Cheshire NHS Trust, Macclesfield, UK. 7. Guy's and St Thomas' Hospital, London, UK. 8. Royal Gwent Hospital, Newport, UK. 9. University of North Tees, Stockton-on-Tees, UK. 10. University Hospital Ayr, NHS Ayrshire and Arran, Ayrshire, UK. 11. James Cook University Hospital, Middlesbrough, UK. 12. Addenbrooke's Hospital, Cambridge, UK. 13. MRC Clinical Trials Unit, University College London, London, UK. 14. Institute for Global Health, University College London, London, UK. 15. Churchill Hospital, Oxford, UK.
Abstract
OBJECTIVE: Refractory symptomatic transudative pleural effusions are an indication for pleural drainage. There has been supportive observational evidence for the use of indwelling pleural catheters (IPCs) for transudative effusions, but no randomised trials. We aimed to investigate the effect of IPCs on breathlessness in patients with transudative pleural effusions when compared with standard care. METHODS: A multicentre randomised controlled trial, in which patients with transudative pleural effusions were randomly assigned to either an IPC (intervention) or therapeutic thoracentesis (TT; standard care). The primary outcome was mean daily breathlessness score over 12 weeks from randomisation. RESULTS: 220 patients were screened from April 2015 to August 2019 across 13 centres, with 33 randomised to intervention (IPC) and 35 to standard care (TT). Underlying aetiology was heart failure in 46 patients, liver failure in 16 and renal failure in six. In primary outcome analysis, the mean±sd breathlessness score over the 12-week study period was 39.7±29.4 mm in the IPC group and 45.0±26.1 mm in the TT group (p=0.67). Secondary outcomes analysis demonstrated that mean±sd drainage was 17 412±17 936 mL and 2901±2416 mL in the IPC and TT groups, respectively. A greater proportion of patients had at least one adverse event in the IPC group (p=0.04). CONCLUSION: We found no significant difference in breathlessness over 12 weeks between IPCs or TT. TT is associated with fewer complications and IPCs reduced the number of invasive pleural procedures required. Patient preference and circumstances should be considered in selecting the intervention in this cohort.
OBJECTIVE: Refractory symptomatic transudative pleural effusions are an indication for pleural drainage. There has been supportive observational evidence for the use of indwelling pleural catheters (IPCs) for transudative effusions, but no randomised trials. We aimed to investigate the effect of IPCs on breathlessness in patients with transudative pleural effusions when compared with standard care. METHODS: A multicentre randomised controlled trial, in which patients with transudative pleural effusions were randomly assigned to either an IPC (intervention) or therapeutic thoracentesis (TT; standard care). The primary outcome was mean daily breathlessness score over 12 weeks from randomisation. RESULTS: 220 patients were screened from April 2015 to August 2019 across 13 centres, with 33 randomised to intervention (IPC) and 35 to standard care (TT). Underlying aetiology was heart failure in 46 patients, liver failure in 16 and renal failure in six. In primary outcome analysis, the mean±sd breathlessness score over the 12-week study period was 39.7±29.4 mm in the IPC group and 45.0±26.1 mm in the TT group (p=0.67). Secondary outcomes analysis demonstrated that mean±sd drainage was 17 412±17 936 mL and 2901±2416 mL in the IPC and TT groups, respectively. A greater proportion of patients had at least one adverse event in the IPC group (p=0.04). CONCLUSION: We found no significant difference in breathlessness over 12 weeks between IPCs or TT. TT is associated with fewer complications and IPCs reduced the number of invasive pleural procedures required. Patient preference and circumstances should be considered in selecting the intervention in this cohort.