Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symptomatic pleural effuion | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Patient reported breathlessness (as measured by VAS dyspnoea score) at 24 hours post pleural fluid removal | VAS dyspnoea score | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Patient reported breathlessness (as measured by VAS dyspnoea score) at other time points post pleural fluid removal |
Not provided
Inclusion Criteria:
Age 18 years or above
Has a unilateral pleural effusion AND
Exclusion Criteria:
Not provided
Not provided
Not provided
Adult patients with unilateral pleural effusions requiring pleural fluid removal via thoracocentesis, chest drain insertion or IPC drainage for management of their breathlessness.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junyi Zhang, MBBChir | Contact | 02071887188 | 56122 | junyi.zhang@gstt.nhs.uk |
| Gillian Radcliffe | Contact | 02071888070 | gillian.radcliffe@gstt.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Patrick Murphy, MBBS BSc | Guy's and St Thomas' NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guy's & St Thomas' NHS Foundation Trust | Recruiting | London | London | SE1 9RT | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26350935 | Result | 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. | |
| 8222812 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|
VAS dyspnoea score |
| pre procedure, immediately post procedure and daily up to and 7 days |
| The effect on exercise capacity of pleural fluid removal. | 6 min walk test | pre procedure, immediately post procedure, 1 day and 7 days |
| Pleural effusion characteristics as measured by thoracic ultrasound | Thoracic ultrasound | 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 | Qualitative feedback form | peri-procedural |
| 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 |
| Ipsilateral hemidiaphragm morphology and movement as measured by thoracic ultrasound. | Thoracic ultrasound | peri-procedural |
| 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 |
| Contralateral hemidiaphragm morphology and movement as measured by thoracic ultrasound. | Thoracic ultrasound | peri-procedural |
| Parasternal intercostal muscle thickness as measured by thoracic ultrasound following pleural fluid removal | Thoracic ultrasound | peri-procedural |
| 25978627 | Result | 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. |
| 6837605 | Result | 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. |
| 28883922 | Result | 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. |
| 32079642 | Result | 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. |
| 21378105 | Result | 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. |
| 3963629 | Result | 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. |
| 31651544 | Result | Skaarup SH, Lonni S, Quadri F, Valsecchi A, Ceruti P, Marchetti G. Ultrasound Evaluation of Hemidiaphragm Function Following Thoracentesis: A Study on Mechanisms of Dyspnea Related to Pleural Effusion. J Bronchology Interv Pulmonol. 2020 Jul;27(3):172-178. doi: 10.1097/LBR.0000000000000627. |
| 35672271 | Result | Fitzgerald DB, Muruganandan S, Peddle-McIntyre CJ, Lee YCG, Singh B. Ipsilateral and contralateral hemidiaphragm dynamics in symptomatic pleural effusion: The 2nd PLeural Effusion And Symptom Evaluation (PLEASE-2) Study. Respirology. 2022 Oct;27(10):882-889. doi: 10.1111/resp.14307. Epub 2022 Jun 7. |
| 15788709 | Result | De Troyer A, Kirkwood PA, Wilson TA. Respiratory action of the intercostal muscles. Physiol Rev. 2005 Apr;85(2):717-56. doi: 10.1152/physrev.00007.2004. |
| 9150337 | Result | Decramer M. Hyperinflation and respiratory muscle interaction. Eur Respir J. 1997 Apr;10(4):934-41. |
| 20956127 | Result | Jolley CJ, Moxham J. A physiological model of patient-reported breathlessness during daily activities in COPD. Eur Respir Rev. 2009 Jun;18(112):66-79. doi: 10.1183/09059180.00000809. |
| 15961606 | Result | Finucane KE, Panizza JA, Singh B. Efficiency of the normal human diaphragm with hyperinflation. J Appl Physiol (1985). 2005 Oct;99(4):1402-11. doi: 10.1152/japplphysiol.01165.2004. Epub 2005 Jun 16. |
| 19265064 | Result | De Troyer A, Wilson TA. Effect of acute inflation on the mechanics of the inspiratory muscles. J Appl Physiol (1985). 2009 Jul;107(1):315-23. doi: 10.1152/japplphysiol.91472.2008. Epub 2009 Mar 5. |
| 33324048 | Result | Wallbridge P, Hew M, Parry SM, Irving L, Steinfort D. Reduction of COPD Hyperinflation by Endobronchial Valves Improves Intercostal Muscle Morphology on Ultrasound. Int J Chron Obstruct Pulmon Dis. 2020 Dec 7;15:3251-3259. doi: 10.2147/COPD.S282829. eCollection 2020. |
| Result | Lalley PM. Respiration - Neural Control. In: Binder MD, Hirokawa N, Windhorst U, editors. Encyclopedia of Neuroscience. Berlin, Heidelberg: Springer Berlin Heidelberg; 2009. p. 3433-41. |
| 6490457 | Result | Killian KJ, Gandevia SC, Summers E, Campbell EJ. Effect of increased lung volume on perception of breathlessness, effort, and tension. J Appl Physiol Respir Environ Exerc Physiol. 1984 Sep;57(3):686-91. doi: 10.1152/jappl.1984.57.3.686. |
| 3933895 | Result | Adams L, Lane R, Shea SA, Cockcroft A, Guz A. Breathlessness during different forms of ventilatory stimulation: a study of mechanisms in normal subjects and respiratory patients. Clin Sci (Lond). 1985 Dec;69(6):663-72. doi: 10.1042/cs0690663. |
| 30956204 | Result | Laveneziana P, Albuquerque A, Aliverti A, Babb T, Barreiro E, Dres M, Dube BP, Fauroux B, Gea J, Guenette JA, Hudson AL, Kabitz HJ, Laghi F, Langer D, Luo YM, Neder JA, O'Donnell D, Polkey MI, Rabinovich RA, Rossi A, Series F, Similowski T, Spengler CM, Vogiatzis I, Verges S. ERS statement on respiratory muscle testing at rest and during exercise. Eur Respir J. 2019 Jun 13;53(6):1801214. doi: 10.1183/13993003.01214-2018. Print 2019 Jun. |
| 18829678 | Result | Jolley CJ, Luo YM, Steier J, Reilly C, Seymour J, Lunt A, Ward K, Rafferty GF, Polkey MI, Moxham J. Neural respiratory drive in healthy subjects and in COPD. Eur Respir J. 2009 Feb;33(2):289-97. doi: 10.1183/09031936.00093408. Epub 2008 Oct 1. |
| 21285244 | Result | Reilly CC, Ward K, Jolley CJ, Lunt AC, Steier J, Elston C, Polkey MI, Rafferty GF, Moxham J. Neural respiratory drive, pulmonary mechanics and breathlessness in patients with cystic fibrosis. Thorax. 2011 Mar;66(3):240-6. doi: 10.1136/thx.2010.142646. Epub 2011 Feb 1. |
| 25323229 | Result | Jolley CJ, Luo YM, Steier J, Rafferty GF, Polkey MI, Moxham J. Neural respiratory drive and breathlessness in COPD. Eur Respir J. 2015 Feb;45(2):355-64. doi: 10.1183/09031936.00063014. Epub 2014 Oct 16. |
| 23504646 | Result | Reilly CC, Jolley CJ, Ward K, MacBean V, Moxham J, Rafferty GF. Neural respiratory drive measured during inspiratory threshold loading and acute hypercapnia in healthy individuals. Exp Physiol. 2013 Jul;98(7):1190-8. doi: 10.1113/expphysiol.2012.071415. Epub 2013 Mar 15. |
| 27779132 | Result | MacBean V, Hughes C, Nicol G, Reilly CC, Rafferty GF. Measurement of neural respiratory drive via parasternal intercostal electromyography in healthy adult subjects. Physiol Meas. 2016 Nov;37(11):2050-2063. doi: 10.1088/0967-3334/37/11/2050. Epub 2016 Oct 25. |
| 21597112 | Result | Murphy PB, Kumar A, Reilly C, Jolley C, Walterspacher S, Fedele F, Hopkinson NS, Man WD, Polkey MI, Moxham J, Hart N. Neural respiratory drive as a physiological biomarker to monitor change during acute exacerbations of COPD. Thorax. 2011 Jul;66(7):602-8. doi: 10.1136/thx.2010.151332. Epub 2011 May 19. |
| 22267769 | Result | Reilly CC, Jolley CJ, Elston C, Moxham J, Rafferty GF. Measurement of parasternal intercostal electromyogram during an infective exacerbation in patients with cystic fibrosis. Eur Respir J. 2012 Oct;40(4):977-81. doi: 10.1183/09031936.00163111. Epub 2012 Jan 20. |
| 30041019 | Result | Lin L, Guan L, Wu W, Chen R. Correlation of surface respiratory electromyography with esophageal diaphragm electromyography. Respir Physiol Neurobiol. 2019 Jan;259:45-52. doi: 10.1016/j.resp.2018.07.004. Epub 2018 Jul 21. |
| 30389829 | Result | Bellani G, Bronco A, Arrigoni Marocco S, Pozzi M, Sala V, Eronia N, Villa G, Foti G, Tagliabue G, Eger M, Pesenti A. Measurement of Diaphragmatic Electrical Activity by Surface Electromyography in Intubated Subjects and Its Relationship With Inspiratory Effort. Respir Care. 2018 Nov;63(11):1341-1349. doi: 10.4187/respcare.06176. |
| 32348374 | Result | Luiso D, Villanueva JA, Belarte-Tornero LC, Fort A, Blazquez-Bermejo Z, Ruiz S, Farre R, Rigau J, Marti-Almor J, Farre N. Surface respiratory electromyography and dyspnea in acute heart failure patients. PLoS One. 2020 Apr 29;15(4):e0232225. doi: 10.1371/journal.pone.0232225. eCollection 2020. |
| 30406935 | Result | Korczynski P, Gorska K, Konopka D, Al-Haj D, Filipiak KJ, Krenke R. Significance of congestive heart failure as a cause of pleural effusion: Pilot data from a large multidisciplinary teaching hospital. Cardiol J. 2020;27(3):254-261. doi: 10.5603/CJ.a2018.0137. Epub 2018 Nov 8. |
| 12091180 | Result | ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. |
| ID | Term |
|---|---|
| D010996 | Pleural Effusion |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided