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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pleural Effusion

Intervention / Treatment
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* Other: Surface parasternal eletromyogram
* Other: Surface diaphragm electromyogram
* Other: Parasternal muscle ultrasound
* Other: Breathlessness assessment


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Symptomatic pleural effuion<br>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<br>* The surface parasternal EMG of participants will be measured pre, immediately post and at days 1 and 7 following pleural fluid removal<br>Other: Surface diaphragm electromyogram<br>* The ipsilateral and contralateral surface diaphragm EMG of participants will be measured pre and immediately post pleural fluid removal<br>Other: Parasternal muscle ultrasound<br>* The thickness of the parasternal intercostal muscle of participants will be measured using thoracic ultrasound pre and immediately post pleural fluid removal<br>Other: Breathlessness assessment<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neural respiratory drive (as measured by surface parasternal EMG) at 24 hours post pleural fluid removal | Neural respiratory drive index (as measured by surface parasternal EMG) | 24 hours | 
| Patient reported breathlessness (as measured by VAS dyspnoea score) at 24 hours post pleural fluid removal | VAS dyspnoea score | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neural respiratory drive (as measured by surface parasternal EMG) at other time points post pleural fluid removal | Neural respiratory drive index (as measured by surface parasternal EMG) | pre procedure, immediately post procedure and daily up to 7 days | 
| Patient reported breathlessness (as measured by VAS dyspnoea score) at other time points post pleural fluid removal | VAS dyspnoea score | pre procedure, immediately post procedure and daily up to and 7 days | 
| The effect on exercise capacity of pleural fluid removal. | 6 min walk test | pre procedure, immediately post procedure, 1 day and 7 days | 
| Pleural effusion characteristics as measured by thoracic ultrasound | Thoracic ultrasound | immediately post procedure, 1 day and 7 days | 
| To determine the acceptability of incorporating surface parasternal EMG measurement as part of routine clinical practice to patients and clinicians | Qualitative feedback form | peri-procedural | 
| Neural respiratory drive (as measured by surface diaphragm EMG) of the ipsilateral hemidiaphragm following thoracocentesis | Neural respiratory drive index (as measured by surface diaphragm EMG) | peri-procedural | 
| Ipsilateral hemidiaphragm morphology and movement as measured by thoracic ultrasound. | Thoracic ultrasound | peri-procedural | 
| Neural respiratory drive (as measured by surface diaphragm EMG) of the contralateral hemidiaphragm following thoracocentesis | Neural respiratory drive index (as measured by surface diaphragm EMG) | peri-procedural | 
| Contralateral hemidiaphragm morphology and movement as measured by thoracic ultrasound. | Thoracic ultrasound | peri-procedural | 
| Parasternal intercostal muscle thickness as measured by thoracic ultrasound following pleural fluid removal | Thoracic ultrasound | peri-procedural | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pleural effusion, Breathlessness, Neural respiratory drive, Neurophysiology