About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or above
Has a unilateral pleural effusion AND
require thoracocentesis OR
chest drain insertion (main study only) OR
Disqualifiers
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
Trial population
Adult patients with unilateral pleural effusions requiring pleural fluid removal via thoracocentesis, chest drain insertion or IPC drainage for management of their breathlessness.
Trial design
Cohort
Prospective
Treatments tested in this trial
Surface parasternal eletromyogram
Other interventionThe surface parasternal EMG of participants will be measured pre, immediately post and at days 1 and 7 following pleural fluid removal
Surface diaphragm electromyogram
Other interventionThe ipsilateral and contralateral surface diaphragm EMG of participants will be measured pre and immediately post pleural fluid removal
Parasternal muscle ultrasound
Other interventionThe thickness of the parasternal intercostal muscle of participants will be measured using thoracic ultrasound pre and immediately post pleural fluid removal
Breathlessness assessment
Other interventionThe 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
Treatment groups
Trial outcomes
Primary outcomes
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)
Patient reported breathlessness (as measured by VAS dyspnoea score) at 24 hours post pleural fluid removal
VAS dyspnoea score
Secondary outcomes
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)
Patient reported breathlessness (as measured by VAS dyspnoea score) at other time points post pleural fluid removal
VAS dyspnoea score
The effect on exercise capacity of pleural fluid removal.
6 min walk test
Pleural effusion characteristics as measured by thoracic ultrasound
Thoracic ultrasound
Sponsors and contacts
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