NCT05945043

Continuation Of a Study to Investigate the Effect of Thoracocentesis on Neural Respiratory Drive in Pleural Effusion

Continuation Of a Study to Investigate the Effect of Thoracocentesis on Neural Respiratory Drive in Pleural Effusion (COSINE)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 124 (estimated)
• Sponsor: Guy's and St Thomas' NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to better understand the relationship between pleural effusions and breathlessness in patients with unilateral pleural effusions and breathlessness who require pleural fluid removal for its management.

Detailed description

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. After being informed about the study, all patients giving written informed consent will undergo a baseline assessment when they first come to have their fluid drained. The investigators will record information about them and their disease. The investigators 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. The investigators 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.

Conditions

• Pleural Effusion

Interventions

Type	Name	Description
OTHER	Surface parasternal eletromyogram	The surface parasternal EMG of participants will be measured pre, immediately post and at days 1 and 7 following pleural fluid removal
OTHER	Surface diaphragm electromyogram	The ipsilateral and contralateral surface diaphragm EMG of participants will be measured pre and immediately post pleural fluid removal
OTHER	Parasternal muscle ultrasound	The thickness of the parasternal intercostal muscle of participants will be measured using thoracic ultrasound pre and immediately post pleural fluid removal
OTHER	Breathlessness assessment	The VAS breathlessness score and Dyspnoea-12 questionnaire of participants will be measured pre, immediately post and at days 1 and 7 following pleural fluid removal

Timeline

• Start date: 2023-11-15
• Primary completion: 2024-12-01
• Completion: 2025-01-01
• First posted: 2023-07-14
• Last updated: 2024-02-28

Locations

1 site across 1 country: United Kingdom