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

Recruiting

• Conditions: Pleural Effusion
• Interventions: Other: Surface parasternal eletromyogram; Other: Surface diaphragm electromyogram; Other: Parasternal muscle ultrasound; Other: Breathlessness assessment

• Registration Number: NCT05945043
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

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.

Study Timeline

• Study First Submitted: 2023-06-07
• Study First Submitted QC: 2023-07-11
• Study First Posted: 2023-07-14
• Study Start: 2023-11-15
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28
• Primary Completion: 2024-12
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 124

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Symptomatic pleural effuion	Surface diaphragm electromyogram	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.
Symptomatic pleural effuion	Parasternal muscle ultrasound	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.
Symptomatic pleural effuion	Breathlessness assessment	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.
Symptomatic pleural effuion	Surface parasternal eletromyogram	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.

Primary Outcome Measures

Name	Time	Method
Patient reported breathlessness (as measured by VAS dyspnoea score) at 24 hours post pleural fluid removal	24 hours	VAS dyspnoea score
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)

Secondary Outcome Measures

Name	Time	Method
Contralateral hemidiaphragm morphology and movement as measured by thoracic ultrasound.	peri-procedural	Thoracic ultrasound
The effect on exercise capacity of pleural fluid removal.	pre procedure, immediately post procedure, 1 day and 7 days	6 min walk test
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)
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)
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
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
Ipsilateral hemidiaphragm morphology and movement as measured by thoracic ultrasound.	peri-procedural	Thoracic ultrasound
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)
Pleural effusion characteristics as measured by thoracic ultrasound	immediately post procedure, 1 day and 7 days	Thoracic ultrasound
Parasternal intercostal muscle thickness as measured by thoracic ultrasound following pleural fluid removal	peri-procedural	Thoracic ultrasound

Trial Locations

Locations (1)

Guy's & St Thomas' NHS Foundation Trust; 🇬🇧 London, United Kingdom