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)

Overview

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.

Interventions

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

Primary outcome measures

• Neural respiratory drive (as measured by surface parasternal EMG) at 24 hours post pleural fluid removal [Time frame: 24 hours]
• Patient reported breathlessness (as measured by VAS dyspnoea score) at 24 hours post pleural fluid removal [Time frame: 24 hours]

Secondary outcome measures (10)

• 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]
• 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]
• The effect on exercise capacity of pleural fluid removal. [Time frame: pre procedure, immediately post procedure, 1 day and 7 days]
• Pleural effusion characteristics as measured by thoracic ultrasound [Time frame: immediately post procedure, 1 day and 7 days]
• To determine the acceptability of incorporating surface parasternal EMG measurement as part of routine clinical practice to patients and clinicians [Time frame: peri-procedural]
• Neural respiratory drive (as measured by surface diaphragm EMG) of the ipsilateral hemidiaphragm following thoracocentesis [Time frame: peri-procedural]
• Ipsilateral hemidiaphragm morphology and movement as measured by thoracic ultrasound. [Time frame: peri-procedural]
• Neural respiratory drive (as measured by surface diaphragm EMG) of the contralateral hemidiaphragm following thoracocentesis [Time frame: peri-procedural]
• Contralateral hemidiaphragm morphology and movement as measured by thoracic ultrasound. [Time frame: peri-procedural]
• Parasternal intercostal muscle thickness as measured by thoracic ultrasound following pleural fluid removal [Time frame: peri-procedural]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United Kingdom · 1 center

• Guy's & St Thomas' NHS Foundation Trust — London

Publications

• Bhatnagar R, Maskell N. The modern diagnosis and management of pleural effusions. BMJ. 2015 Sep 8;351:h4520. doi: 10.1136/bmj.h4520. No abstract available. PMID 26350935
• Marel M, Zrustova M, Stasny B, Light RW. The incidence of pleural effusion in a well-defined region. Epidemiologic study in central Bohemia. Chest. 1993 Nov;104(5):1486-9. doi: 10.1378/chest.104.5.1486. PMID 8222812
• Thomas R, Jenkins S, Eastwood PR, Lee YC, Singh B. Physiology of breathlessness associated with pleural effusions. Curr Opin Pulm Med. 2015 Jul;21(4):338-45. doi: 10.1097/MCP.0000000000000174. PMID 25978627
• Estenne M, Yernault JC, De Troyer A. Mechanism of relief of dyspnea after thoracocentesis in patients with large pleural effusions. Am J Med. 1983 May;74(5):813-9. doi: 10.1016/0002-9343(83)91072-0. PMID 6837605
• Psallidas I, Yousuf A, Talwar A, Hallifax RJ, Mishra EK, Corcoran JP, Ali N, Rahman NM. Assessment of patient-reported outcome measures in pleural interventions. BMJ Open Respir Res. 2017 Jul 3;4(1):e000171. doi: 10.1136/bmjresp-2016-000171. eCollection 2017. PMID 28883922
• Muruganandan S, Azzopardi M, Thomas R, Fitzgerald DB, Kuok YJ, Cheah HM, Read CA, Budgeon CA, Eastwood PR, Jenkins S, Singh B, Murray K, Lee YCG. The Pleural Effusion And Symptom Evaluation (PLEASE) study of breathlessness in patients with a symptomatic pleural effusion. Eur Respir J. 2020 May 14;55(5):1900980. doi: 10.1183/13993003.00980-2019. Print 2020 May. PMID 32079642
• Nishino T. Dyspnoea: underlying mechanisms and treatment. Br J Anaesth. 2011 Apr;106(4):463-74. doi: 10.1093/bja/aer040. Epub 2011 Mar 4. PMID 21378105
• Light RW, Stansbury DW, Brown SE. The relationship between pleural pressures and changes in pulmonary function after therapeutic thoracentesis. Am Rev Respir Dis. 1986 Apr;133(4):658-61. doi: 10.1164/arrd.1986.133.4.658. PMID 3963629

Identifiers

NCT: NCT05945043 · 322762

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗