PLeural Effusion and Symptom Evaluation (PLEASE) study on the pathophysiology of breathlessness in patients with symptomatic pleural effusions

Not Applicable

Recruiting

• Conditions: Pleural Effusion; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12616000820404
• Lead Sponsor: Professor YC Gary Lee

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Suitable participants are those with symptomatic pleural effusion who require therapeutic pleural drainage (by needle aspiration, intercostal catheter (ICC) or indwelling pleural catheter (IPC)) as part of standard clinical care for management of the effusion and are able to provide written informed consent.

Exclusion Criteria

Exclusion Criteria include patients who:
1.are <18 years;
2.require urgent pleural drainage performed before pre-assessment protocol tests can be completed;
3.are unable to perform lung function and exercise tests, or are unable to comply with the protocol; and
4.are pregnant or lactating.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in severity of breathlessness following drainage of pleural effusion. <br><br>Instruments: <br>1) 100mm Visual Analogue Scale at rest, b) Dyspnea-12 Questionnaire at rest and c) Modified Borg 0-10 scale at rest prior to the six-minute walk test and the peak level of breathlessness evoked during the test. [Assessments will be performed immediately pre-drainage of the pleural effusion and repeated 24-48 hours post-drainage. ]