The modern diagnosis and management of pleural effusions.
Rahul Bhatnagar, Nick Maskell
https://pubmed.ncbi.nlm.nih.gov/26350935Actively Recruiting
Age: 18Years +
All Genders
ID05945043
Continuation of a Study to Investigate the Effect of Thoracocentesis on Neural Respiratory Drive in Pleural Effusion (COSINE)
Led by Guy's and St Thomas' NHS Foundation Trust · Updated on 2026-06-04
124
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the relationship between pleural effusions and breathlessness in adults with unilateral pleural effusions who need fluid removal to manage their symptoms. This observational study will enroll 124 adults over an 18-month period to better understand how removing pleural fluid affects the electrical activity of breathing muscles and patient breathlessness. Participants will undergo measurements including surface parasternal and diaphragm electromyograms (EMG) and parasternal muscle ultrasounds. These assessments will be done before, immediately after, and at 1 and 7 days following pleural fluid removal, which may be done via thoracocentesis, chest drain insertion, or indwelling pleural catheter (IPC). Breathlessness will be measured using the VAS dyspnoea score and Dyspnoea-12 questionnaire. During the study, patients will be evaluated at baseline, immediately post-procedure, and at 1 and 7 days after fluid removal. Researchers will collect data on neural respiratory drive, breathlessness, exercise capacity, and pleural effusion characteristics using thoracic ultrasound. The study will also assess how acceptable it is to include surface parasternal EMG as part of routine clinical practice. Participants will be monitored for up to 7 days post-procedure.
CONDITIONS
Brief Title
Continuation Of a Study to Investigate the Effect of Thoracocentesis on Neural Respiratory Drive in Pleural Effusion
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or above
- Have a unilateral pleural effusion
- Require pleural fluid removal by thoracocentesis, chest drain insertion, or have an indwelling pleural catheter in place
You will not qualify if you...
- Unable to give informed consent
- Have any contraindications to the planned pleural procedure
- Have haemodynamic or clinical instability preventing safe pre-procedural measurements
- Unable to identify landmarks for surface EMG electrode placement
- Have a history of diaphragmatic paralysis (for the diaphragm sub-study only)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Monitoring
Duration - 7 days
Participants undergo pleural fluid removal and have measurements taken before, immediately after, and up to 7 days following the procedure to assess breathlessness, breathing muscle activity, and muscle thickness using EMG and ultrasound.
4 visits: pre-procedure, immediately post-procedure, Day 1, and Day 7 (in-person)
Trial Site Locations
Total: 1 location
1
Guy's & St Thomas' NHS Foundation Trust
London, London, United Kingdom, SE1 9RT
Actively Recruiting
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Research Team
J
Junyi Zhang, MBBChir
G
Gillian Radcliffe
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
The incidence of pleural effusion in a well-defined region. Epidemiologic study in central Bohemia.
M Marel, M Zrůstová, B Stasný...
https://pubmed.ncbi.nlm.nih.gov/8222812Physiology of breathlessness associated with pleural effusions.
Rajesh Thomas, Susan Jenkins, Peter R Eastwood...
https://pubmed.ncbi.nlm.nih.gov/25978627Mechanism of relief of dyspnea after thoracocentesis in patients with large pleural effusions.
M Estenne, J C Yernault, A De Troyer
https://pubmed.ncbi.nlm.nih.gov/6837605Assessment of patient-reported outcome measures in pleural interventions.
Ioannis Psallidas, Ahmed Yousuf, Ambika Talwar...
https://pubmed.ncbi.nlm.nih.gov/28883922The Pleural Effusion And Symptom Evaluation (PLEASE) study of breathlessness in patients with a symptomatic pleural effusion.
Sanjeevan Muruganandan, Maree Azzopardi, Rajesh Thomas...
https://pubmed.ncbi.nlm.nih.gov/32079642Dyspnoea: underlying mechanisms and treatment.
T Nishino
https://pubmed.ncbi.nlm.nih.gov/21378105The relationship between pleural pressures and changes in pulmonary function after therapeutic thoracentesis.
R W Light, D W Stansbury, S E Brown
https://pubmed.ncbi.nlm.nih.gov/3963629Ultrasound Evaluation of Hemidiaphragm Function Following Thoracentesis: A Study on Mechanisms of Dyspnea Related to Pleural Effusion.
Søren H Skaarup, Sara Lonni, Federico Quadri...
https://pubmed.ncbi.nlm.nih.gov/31651544Ipsilateral and contralateral hemidiaphragm dynamics in symptomatic pleural effusion: The 2nd PLeural Effusion And Symptom Evaluation (PLEASE-2) Study.
Deirdre B Fitzgerald, Sanjeevan Muruganandan, Carolyn J Peddle-McIntyre...
https://pubmed.ncbi.nlm.nih.gov/35672271