Using Ultrasound to Predict the Results of Draining Pleural Effusions

NCT01973985 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 2

Last updated 2018-01-10

No results posted yet for this study

Summary

Pleural effusion is an extremely common problem with multiple causes; its subsequent investigation with thoracocentesis and treatment with drainage represent two of the most frequently performed diagnostic and therapeutic medical procedures. The role of thoracic ultrasonography in the management of pleural effusion is a modern and rapidly expanding one, having become effectively mandatory and part of the "gold standard" over the past decade due to its diagnostic and patient safety benefits. By contrast, the measurement of intra-pleural pressure using sequential manometry has failed to convincingly demonstrate its clinical value beyond physiological studies despite its availability for over a century. Previous work has shown a potential role for pleural manometry in predicting the presence of un-expandable lung and success of talc pleurodesis but these studies have not been replicated or clinically validated.

We intend to combine the old and new in an observational study comparing findings on thoracic ultrasonography and pleural manometry during thoracocentesis with patient-reported symptoms and the key clinical outcomes of presence of un-expandable lung and success of talc pleurodesis. The investigators hypothesise that the previously described variations in pleural elastance can be correlated with appearances and anatomical changes visualised on thoracic ultrasonography; and in combination can be reliably utilised to predict clinical outcome. The study may allow the proposal of a treatment algorithm that allows patients with pleural effusion to be managed in a more expeditious and efficient manner.

Conditions

  • Pleural Effusion

Interventions

OTHER

Pleural Manometry

Intrapleural pressure will be monitored with the use of an electronic pleural manometer (Mirador Biomedical CompassTM Thoracentesis Assist Device).

OTHER

Thoracic ultrasonography

Thoracic ultrasound scan will be done before drainage of pleural effusion - all participants. Thoracic ultrasound scans will also be done during drainage of pleural effusion and the results will be recorded after every 100mL of pleural fluid drained - all participants. Thoracic ultrasound scan will be done after drainage of pleural effusion - all participants. Thoracic ultrasound scan will also be be done during clinic follow-up as part of routine clinical care - all participants.

PROCEDURE

Pleural aspiration catheter OR chest drain (standard care)

Insertion of pleural aspiration catheter OR intercostal chest drain under ultrasound guidance - all participants (standard care).

PROCEDURE

Talc slurry pleurodesis via chest drain (standard care)

Talc slurry pleurodesis via intercostal chest drain where/when clinically indicated as part of routine clinical care participants with intercostal chest drain only (standard care).

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Principal Investigators

  • Najib Rahman, DPhil, MSc, MRCP · University of Oxford & Oxford University Hospitals NHS Trust

  • John Corcoran, MD · University of Oxford

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-01
Primary Completion
2017-05-16
Completion
2017-05-16

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01973985 on ClinicalTrials.gov