ClinicalTrials.gg
RecruitingNCT05945043COSINEUpdated Jun 4, 2026

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

An observational study in Pleural Effusion, sponsored by Guy's and St Thomas' NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-04.

Sponsored by Guy's and St Thomas' NHS Foundation Trust · Observational

From the registry’s dates

  • Started Nov 2023; still recruiting 2 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
124
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Pleural Effusion

Keywords

  • Pleural effusion
  • Breathlessness
  • Neural respiratory drive
  • Neurophysiology
03

In context

Pleural Effusion

241 studies on the registry are indexed under Pleural Effusion; 50 are open to participants now.

This study's planned enrollment of 124 is below the median of 140 across 93 observational studies indexed under Pleural Effusion.

Browse Pleural Effusion studies →

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust is the lead sponsor of 295 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients with unilateral pleural effusions requiring pleural fluid removal via thoracocentesis, chest drain insertion or IPC drainage for management of their breathlessness.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Inability to consent
  • Any 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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
124 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

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

Interventions

  • OtherSurface parasternal eletromyogram

    The surface parasternal EMG of participants will be measured pre, immediately post and at days 1 and 7 following pleural fluid removal

  • OtherSurface diaphragm electromyogram

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

  • OtherParasternal muscle ultrasound

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

  • OtherBreathlessness 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

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 24 hours

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

    VAS dyspnoea score

    Time frame: 24 hours

Secondary outcomes

  1. 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)

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

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

    VAS dyspnoea score

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

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

    6 min walk test

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

  4. Pleural effusion characteristics as measured by thoracic ultrasound

    Thoracic ultrasound

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

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

    Qualitative feedback form

    Time frame: peri-procedural

  6. 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)

    Time frame: peri-procedural

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

    Thoracic ultrasound

    Time frame: peri-procedural

  8. 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)

    Time frame: peri-procedural

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

    Thoracic ultrasound

    Time frame: peri-procedural

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

    Thoracic ultrasound

    Time frame: peri-procedural

07

Study locations

1 of 1 sites recruiting
08

References and documents

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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 3963629 ↗
  • 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. PubMed 31651544 ↗
  • 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. PubMed 35672271 ↗
  • 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. PubMed 15788709 ↗
  • Decramer M. Hyperinflation and respiratory muscle interaction. Eur Respir J. 1997 Apr;10(4):934-41. PubMed 9150337 ↗
  • 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. PubMed 20956127 ↗
  • 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. PubMed 15961606 ↗
  • 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. PubMed 19265064 ↗
  • 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. PubMed 33324048 ↗
  • 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.
  • 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. PubMed 6490457 ↗
  • 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. PubMed 3933895 ↗
  • 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. PubMed 30956204 ↗
  • 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. PubMed 18829678 ↗
  • 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. PubMed 21285244 ↗
  • 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. PubMed 25323229 ↗
  • 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. PubMed 23504646 ↗
  • 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. PubMed 27779132 ↗
  • 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. PubMed 21597112 ↗
  • 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. PubMed 22267769 ↗
  • 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. PubMed 30041019 ↗
  • 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. PubMed 30389829 ↗
  • 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. PubMed 32348374 ↗
  • 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. PubMed 30406935 ↗
  • 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. PubMed 12091180 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2023 (actual). Primary completion is estimated for Jun 2027, 43 months after the start.

Of 35 observational studies under Pleural Effusion, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 48. This study's planned 43 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 7, 2023
First posted
Jul 14, 2023
StartActual
Nov 15, 2023
Primary completionEst.
Jun 30, 2027
CompletionEst.
Jun 30, 2027
Last update
Jun 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05945043
Responsible party
Sponsor
First posted
Jul 14, 2023
Start date
Nov 15, 2023
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Jun 4, 2026

Study contacts

Junyi Zhang, MBBChir
Contact
junyi.zhang@gstt.nhs.uk
02071887188 ext. 56122
Gillian Radcliffe
Contact
gillian.radcliffe@gstt.nhs.uk
02071888070
Patrick Murphy, MBBS BSc
principal investigator · Guy's and St Thomas' NHS Foundation Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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