Guy's & St Thomas' NHS Foundation Trust
London, SE1 9RT, United Kingdom
Location status: Recruiting
NCT Number: NCT05945043
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
London, SE1 9RT, United Kingdom
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The surface parasternal EMG of participants will be measured pre, immediately post and at days 1 and 7 following pleural fluid removal
The ipsilateral and contralateral surface diaphragm EMG of participants will be measured pre and immediately post pleural fluid removal
The thickness of the parasternal intercostal muscle of participants will be measured using thoracic ultrasound pre and immediately post pleural fluid removal
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
Time frame: 24 hours
Neural respiratory drive index (as measured by surface parasternal EMG)
Time frame: 24 hours
VAS dyspnoea score
Time frame: pre procedure, immediately post procedure and daily up to 7 days
Neural respiratory drive index (as measured by surface parasternal EMG)
Time frame: pre procedure, immediately post procedure and daily up to and 7 days
VAS dyspnoea score
Time frame: pre procedure, immediately post procedure, 1 day and 7 days
6 min walk test
Time frame: immediately post procedure, 1 day and 7 days
Thoracic ultrasound
Time frame: peri-procedural
Qualitative feedback form
Time frame: peri-procedural
Neural respiratory drive index (as measured by surface diaphragm EMG)
Time frame: peri-procedural
Thoracic ultrasound
Time frame: peri-procedural
Neural respiratory drive index (as measured by surface diaphragm EMG)
Time frame: peri-procedural
Thoracic ultrasound
Time frame: peri-procedural
Thoracic ultrasound
Contact information is provided by the study sponsor or research team.
Guy's and St Thomas' NHS Foundation Trust
Other
Continuation Of a Study to Investigate the Effect of Thoracocentesis on Neural Respiratory Drive in Pleural Effusion (COSINE)
Acronym: COSINE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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