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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (10)

• Neural respiratory drive (as measured by surface parasternal EMG) at other time points post pleural fluid removal [Срок оценки: 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 [Срок оценки: pre procedure, immediately post procedure and daily up to and 7 days]
• The effect on exercise capacity of pleural fluid removal. [Срок оценки: pre procedure, immediately post procedure, 1 day and 7 days]
• Pleural effusion characteristics as measured by thoracic ultrasound [Срок оценки: 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 [Срок оценки: peri-procedural]
• Neural respiratory drive (as measured by surface diaphragm EMG) of the ipsilateral hemidiaphragm following thoracocentesis [Срок оценки: peri-procedural]
• Ipsilateral hemidiaphragm morphology and movement as measured by thoracic ultrasound. [Срок оценки: peri-procedural]
• Neural respiratory drive (as measured by surface diaphragm EMG) of the contralateral hemidiaphragm following thoracocentesis [Срок оценки: peri-procedural]
• Contralateral hemidiaphragm morphology and movement as measured by thoracic ultrasound. [Срок оценки: peri-procedural]
• Parasternal intercostal muscle thickness as measured by thoracic ultrasound following pleural fluid removal [Срок оценки: peri-procedural]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Великобритания · 1 центр

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

Публикации

• 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

Идентификаторы

NCT: NCT05945043 · 322762

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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