Clinical trial NCT05945043: Continuation Of a Study to Investigate the Effect of Thoracocentesis on Neural Respiratory Drive in Pleural Effusion
Official title: Continuation Of a Study to Investigate the Effect of Thoracocentesis on Neural Respiratory Drive in Pleural Effusion (COSINE)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pleural Effusion
Keywords: Pleural effusion
Breathlessness
Neural respiratory drive
Neurophysiology
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with unilateral pleural effusions requiring pleural fluid removal via thoracocentesis, chest drain insertion or IPC drainage for management of their breathlessness.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Neural respiratory drive (as measured by surface parasternal EMG) at 24 hours post pleural fluid removal
timeFrame: 24 hours
measure: Patient reported breathlessness (as measured by VAS dyspnoea score) at 24 hours post pleural fluid removal
timeFrame: 24 hours
Secondary outcomes:
measure: Neural respiratory drive (as measured by surface parasternal EMG) at other time points post pleural fluid removal
timeFrame: pre procedure, immediately post procedure and daily up to 7 days
measure: Patient reported breathlessness (as measured by VAS dyspnoea score) at other time points post pleural fluid removal
timeFrame: pre procedure, immediately post procedure and daily up to and 7 days
measure: The effect on exercise capacity of pleural fluid removal.
timeFrame: pre procedure, immediately post procedure, 1 day and 7 days
measure: Pleural effusion characteristics as measured by thoracic ultrasound
timeFrame: immediately post procedure, 1 day and 7 days
measure: To determine the acceptability of incorporating surface parasternal EMG measurement as part of routine clinical practice to patients and clinicians
timeFrame: peri-procedural
measure: Neural respiratory drive (as measured by surface diaphragm EMG) of the ipsilateral hemidiaphragm following thoracocentesis
timeFrame: peri-procedural
measure: Ipsilateral hemidiaphragm morphology and movement as measured by thoracic ultrasound.
timeFrame: peri-procedural
measure: Neural respiratory drive (as measured by surface diaphragm EMG) of the contralateral hemidiaphragm following thoracocentesis
timeFrame: peri-procedural
measure: Contralateral hemidiaphragm morphology and movement as measured by thoracic ultrasound.
timeFrame: peri-procedural
measure: Parasternal intercostal muscle thickness as measured by thoracic ultrasound following pleural fluid removal
timeFrame: peri-procedural
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's & St Thomas' NHS Foundation Trust
Study officials:
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: Patrick Murphy, MBBS BSc
role: PRINCIPAL_INVESTIGATOR
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