COSINE: Continuation Of a Study to Investigate the Effect of Thoracocentesis on Neural Respiratory Drive in Pleural Effusion
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Symptomatic pleural effuion Patients with symptomatic unilateral pleural effusion of any cause who will be undergoing pleural fluid removal via thoracocentesis, chest drain insertion or IPC drainage for relief of their breathlessness. |
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
|
Outcome Measures
Primary Outcome Measures
- Neural respiratory drive (as measured by surface parasternal EMG) at 24 hours post pleural fluid removal [24 hours]
Neural respiratory drive index (as measured by surface parasternal EMG)
- Patient reported breathlessness (as measured by VAS dyspnoea score) at 24 hours post pleural fluid removal [24 hours]
VAS dyspnoea score
Secondary Outcome Measures
- Neural respiratory drive (as measured by surface parasternal EMG) at other time points post pleural fluid removal [pre procedure, immediately post procedure and daily up to 7 days]
Neural respiratory drive index (as measured by surface parasternal EMG)
- Patient reported breathlessness (as measured by VAS dyspnoea score) at other time points post pleural fluid removal [pre procedure, immediately post procedure and daily up to and 7 days]
VAS dyspnoea score
- The effect on exercise capacity of pleural fluid removal. [pre procedure, immediately post procedure, 1 day and 7 days]
6 min walk test
- Pleural effusion characteristics as measured by thoracic ultrasound [immediately post procedure, 1 day and 7 days]
Thoracic ultrasound
- To determine the acceptability of incorporating surface parasternal EMG measurement as part of routine clinical practice to patients and clinicians [peri-procedural]
Qualitative feedback form
- Neural respiratory drive (as measured by surface diaphragm EMG) of the ipsilateral hemidiaphragm following thoracocentesis [peri-procedural]
Neural respiratory drive index (as measured by surface diaphragm EMG)
- Ipsilateral hemidiaphragm morphology and movement as measured by thoracic ultrasound. [peri-procedural]
Thoracic ultrasound
- Neural respiratory drive (as measured by surface diaphragm EMG) of the contralateral hemidiaphragm following thoracocentesis [peri-procedural]
Neural respiratory drive index (as measured by surface diaphragm EMG)
- Contralateral hemidiaphragm morphology and movement as measured by thoracic ultrasound. [peri-procedural]
Thoracic ultrasound
- Parasternal intercostal muscle thickness as measured by thoracic ultrasound following pleural fluid removal [peri-procedural]
Thoracic ultrasound
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 18 years or above
-
Has a unilateral pleural effusion AND
-
require thoracocentesis OR
-
chest drain insertion (main study only) OR
-
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Guy's & St Thomas' NHS Foundation Trust | London | United Kingdom | SE1 9RT |
Sponsors and Collaborators
- Guy's and St Thomas' NHS Foundation Trust
Investigators
- Principal Investigator: Patrick Murphy, MBBS BSc, Guy's and St Thomas' NHS Foundation Trust
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 322762