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NCT Number: NCT05945043

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Guy's & St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

Location status: Recruiting

Location contact

Gill Radcliffe

CONTACT

[email protected]

02071888070

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or above
  • Has a unilateral pleural effusion AND
  • require thoracocentesis OR
  • chest drain insertion (main study only) OR
  • 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)

Treatment and study plan

Surface parasternal eletromyogram

Other

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

Other

The ipsilateral and contralateral surface diaphragm EMG of participants will be measured pre and immediately post pleural fluid removal

Parasternal muscle ultrasound

Other

The thickness of the parasternal intercostal muscle of participants will be measured using thoracic ultrasound pre and immediately post pleural fluid removal

Breathlessness assessment

Other

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

Primary outcomes

  1. Neural respiratory drive (as measured by surface parasternal EMG) at 24 hours post pleural fluid removal

    Time frame: 24 hours

    Neural respiratory drive index (as measured by surface parasternal EMG)

  2. Patient reported breathlessness (as measured by VAS dyspnoea score) at 24 hours post pleural fluid removal

    Time frame: 24 hours

    VAS dyspnoea score

Secondary outcomes

  1. Neural respiratory drive (as measured by surface parasternal EMG) at other time points post pleural fluid removal

    Time frame: pre procedure, immediately post procedure and daily up to 7 days

    Neural respiratory drive index (as measured by surface parasternal EMG)

  2. Patient reported breathlessness (as measured by VAS dyspnoea score) at other time points post pleural fluid removal

    Time frame: pre procedure, immediately post procedure and daily up to and 7 days

    VAS dyspnoea score

  3. The effect on exercise capacity of pleural fluid removal.

    Time frame: pre procedure, immediately post procedure, 1 day and 7 days

    6 min walk test

  4. Pleural effusion characteristics as measured by thoracic ultrasound

    Time frame: immediately post procedure, 1 day and 7 days

    Thoracic ultrasound

  5. To determine the acceptability of incorporating surface parasternal EMG measurement as part of routine clinical practice to patients and clinicians

    Time frame: peri-procedural

    Qualitative feedback form

  6. Neural respiratory drive (as measured by surface diaphragm EMG) of the ipsilateral hemidiaphragm following thoracocentesis

    Time frame: peri-procedural

    Neural respiratory drive index (as measured by surface diaphragm EMG)

  7. Ipsilateral hemidiaphragm morphology and movement as measured by thoracic ultrasound.

    Time frame: peri-procedural

    Thoracic ultrasound

  8. Neural respiratory drive (as measured by surface diaphragm EMG) of the contralateral hemidiaphragm following thoracocentesis

    Time frame: peri-procedural

    Neural respiratory drive index (as measured by surface diaphragm EMG)

  9. Contralateral hemidiaphragm morphology and movement as measured by thoracic ultrasound.

    Time frame: peri-procedural

    Thoracic ultrasound

  10. Parasternal intercostal muscle thickness as measured by thoracic ultrasound following pleural fluid removal

    Time frame: peri-procedural

    Thoracic ultrasound

Study contacts

Contact information is provided by the study sponsor or research team.

Gillian Radcliffe

CONTACT

[email protected]

02071888070

Junyi Zhang, MBBChir

CONTACT

[email protected]

02071887188 ext. 56122

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Registry information

Official study title

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

Acronym: COSINE

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 14, 2023
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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