Pleural Effusion
Conditions
Keywords
Pleural effusion, Breathlessness, Neural respiratory drive, Neurophysiology
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.
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.
Interventions
OTHERSurface parasternal eletromyogram
The surface parasternal EMG of participants will be measured pre, immediately post and at days 1 and 7 following pleural fluid removal
OTHERSurface diaphragm electromyogram
The ipsilateral and contralateral surface diaphragm EMG of participants will be measured pre and immediately post pleural fluid removal
OTHERParasternal muscle ultrasound
The thickness of the parasternal intercostal muscle of participants will be measured using thoracic ultrasound pre and immediately post pleural fluid removal
OTHERBreathlessness 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
Sponsors
Guy's and St Thomas' NHS Foundation Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United Kingdom
Contacts
CONTACTJunyi Zhang, MBBChir
CONTACTGillian Radcliffe
PRINCIPAL_INVESTIGATORPatrick Murphy, MBBS BSc
Guy's and St Thomas' NHS Foundation Trust
Outcome results
None listed