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

Guy's and St Thomas' NHS Foundation Trust

Status: Enrolling

Conditions: Pleural Effusion

Treatments: Other: Breathlessness assessment; Other: Parasternal muscle ultrasound; Other: Surface parasternal eletromyogram; Other: Surface diaphragm electromyogram

Study type: Observational

Funder types: Other

Identifiers

NCT05945043

322762

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

124 participants in 1 patient group

Symptomatic pleural effuion

Description:

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.

Treatment:

Other: Surface parasternal eletromyogram

Other: Breathlessness assessment

Other: Parasternal muscle ultrasound

Other: Surface diaphragm electromyogram