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

Pleural Effusion Clinical Trial

— COSINE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05945043
• Other study ID #: 322762
• Status: Recruiting
• Start date: November 15, 2023
• Est. completion date: January 2025

Study information

• Verified date: February 2024
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Junyi Zhang, MBBChir
• Phone: 02071887188
• Email: junyi.zhang[@]gstt.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pleural Effusion

Intervention

Other:
• Surface parasternal eletromyogram
The surface parasternal EMG of participants will be measured pre, immediately post and at days 1 and 7 following pleural fluid removal
• Surface diaphragm electromyogram
The ipsilateral and contralateral surface diaphragm EMG of participants will be measured pre and immediately post pleural fluid removal
• Parasternal muscle ultrasound
The thickness of the parasternal intercostal muscle of participants will be measured using thoracic ultrasound pre and immediately post pleural fluid removal
• Breathlessness 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

Locations

Country	Name	City	State
United Kingdom	Guy's & St Thomas' NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Patient reported breathlessness (as measured by VAS dyspnoea score) at 24 hours post pleural fluid removal	VAS dyspnoea score	24 hours
Secondary	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
Secondary	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
Secondary	The effect on exercise capacity of pleural fluid removal.	6 min walk test	pre procedure, immediately post procedure, 1 day and 7 days
Secondary	Pleural effusion characteristics as measured by thoracic ultrasound	Thoracic ultrasound	immediately post procedure, 1 day and 7 days
Secondary	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
Secondary	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
Secondary	Ipsilateral hemidiaphragm morphology and movement as measured by thoracic ultrasound.	Thoracic ultrasound	peri-procedural
Secondary	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
Secondary	Contralateral hemidiaphragm morphology and movement as measured by thoracic ultrasound.	Thoracic ultrasound	peri-procedural
Secondary	Parasternal intercostal muscle thickness as measured by thoracic ultrasound following pleural fluid removal	Thoracic ultrasound	peri-procedural