Investigating how draining fluid from the lungs affects breathing in patients with pleural effusion
Continuation Of a Study to Investigate the Effect of Thoracocentesis on Neural Respiratory Drive in Pleural Effusion (COSINE)
This study is trying to see how draining fluid from the lungs affects breathing and breathlessness in adults with pleural effusion.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 124 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Guy's and St Thomas' NHS Foundation Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT05945043 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between pleural effusions and breathlessness in patients requiring fluid removal. It will involve 124 adult patients with unilateral pleural effusions, recruited from a single center in the UK over 18 months. Participants will undergo baseline assessments, including measurements of breathlessness, breathing muscle activity, and electrical signals from the brain to these muscles, at various time points around the drainage procedure. The goal is to identify links between pleural effusion removal and changes in breathing dynamics and patient-reported breathlessness.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with unilateral pleural effusions who require thoracocentesis or related procedures.
Not a fit: Patients who are unable to consent or have contraindications to pleural procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of breathlessness management in patients with pleural effusions, potentially leading to improved treatment strategies.
How similar studies have performed: While similar studies have explored aspects of pleural effusions and breathlessness, this specific approach to measuring neural respiratory drive is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or above * Has a unilateral pleural effusion AND 1. require thoracocentesis OR 2. chest drain insertion (main study only) OR 3. has an IPC in situ (main study only) Exclusion Criteria: * Inability to consent * Any contraindications to the proposed pleural procedure * Haemodynamic or clinical instability that precludes from the safe completion of required pre-procedural measurements * Inability to identify surface landmarks for surface EMG electrode placement * Past medical history of diaphragmatic paralysis (diaphragm sub study only)
Where this trial is running
London
- Guy's & St Thomas' NHS Foundation Trust — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Patrick Murphy, MBBS BSc — Guy's and St Thomas' NHS Foundation Trust
- Study coordinator: Junyi Zhang, MBBChir
- Email: junyi.zhang@gstt.nhs.uk
- Phone: 02071887188
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.