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Trial registered on ANZCTR
Registration number
ACTRN12616000820404
Ethics application status
Approved
Date submitted
18/06/2016
Date registered
22/06/2016
Date last updated
22/06/2016
Type of registration
Retrospectively registered
Titles & IDs
Public title
PLeural Effusion and Symptom Evaluation (PLEASE) study on the pathophysiology of breathlessness in patients with symptomatic pleural effusions
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Scientific title
PLeural Effusion and Symptom Evaluation (PLEASE) study on the pathophysiology of breathlessness in patients with symptomatic pleural effusions
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Secondary ID [1]
289472
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Nil Known
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Universal Trial Number (UTN)
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Trial acronym
PLEASE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pleural Effusion
299153
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Condition category
Condition code
Respiratory
299171
299171
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
The PLEASE study is a single centre prospective study of 150 patients with symptomatic pleural effusions that require therapeutic drainage. The study aims to identify key factors that underlie breathlessness in pleural effusion patients and develop predictors of improvement in breathlessness following effusion drainage. Participants will undergo evaluation pre- and post-effusion drainage to assess functional impairment at rest and during exercise, respiratory and other physiological responses and respiratory muscle mechanics.
Study Measurements include:
1. Baseline assessment (1.5 hours): All participants will be interviewed and examined prior to pleural drainage
i) Patient data – Demographics, comorbidities (e.g. COPD, heart disease), underlying cancer (type, stage and treatment, etc.) and relevant clinical data including cardio-pulmonary status (respiratory rate, heart rate, blood pressure and oxygen saturation by pulse oximetry) will be recorded.
ii) Pleural effusion characteristics – This will include the etiology of the effusion (if known) and the details of any prior pleural procedures.
iii) Measurement of breathlessness - Breathlessness will be assessed using three instruments; a) Visual Analogue Scale b) Dyspnea-12 Questionnaire and c) Modified Borg 0-10 scale. The VAS score is a validated measure of breathlessness in malignant pleural effusion and has been used in clinical trials involving MPE cohorts. The participant places a mark on the 100mm vertical scale to indicate the severity of their breathlessness. A score of 0mm indicates the most severe breathlessness. The Dyspnea-12 Questionnaire has demonstrated validity and reliability in COPD, asthma, interstitial lung disease and pulmonary arterial hypertension. It consists of 12 questions with physical and affective components. Each question is scored 0-3 points, with a total maximum score of 36 points indicating the most severe level of dyspnoea. The modified Borg scale 0-10 scale will be used to assess exertional dyspnoea evoked during the six-minute walk test.
iv) Measurement of functional capacity - Functional exercise capacity will be assessed using the 6-minute walk test. The distance walked, (i.e. 6MWD) will be expressed as an absolute distance (m) and as a percentage of the patient’s predicted 6MWD derived from a reference equation developed locally in healthy individuals.
v) Measurements of lung physiology: Detailed lung function including spirometry, lung volumes and gas transfer measurements will be performed as per the American Thoracic Society recommendations, provided that there are no contra-indications.
vii) Measurements of diaphragmatic morphology and function: Pleural ultrasound will be employed to assess diaphragm i) shape - normal (domed), flattened or inverted; and ii) movement - the zone of apposition (Zapp) of the diaphragm at the costo-phrenic angle will be measured.
viii) Radiological assessment of size of effusion: Effusions will be graded based on their radiographic appearance into five categories (where 0 = no effusion, and 5 = >75% of hemithorax). The presence of other radiographic abnormalities (eg. presence of mediastinal shift, trapped lung and fluid loculations) will also be recorded.
2. Pleural Drainage (1 hour): The fluid will be removed at a controlled rate to ensure patient safety as per international clinical guidelines. Data collected at the time of pleural drainage will include:
i) Total volume and duration of pleural fluid drainage.
ii) Measurements of pleural pressure using a digital manometer [Compass, Mirador Biomedical, Inc, Seattle, USA] - In a subgroup of patients, end-inspiratory and end-expiratory pleural pressure measurements will be recorded at opening pressure, after every 100mL of drainage up to 1000mLs and at closing pressure.
iii) Pleural fluid macroscopic appearance and biochemical analysis (e.g. pleural fluid pH and levels of protein, lactate dehydrogenase and glucose).
3. Repeat Testing (1.5 hours): The pre-drainage tests will be repeated between 24 and 36 hours after completion of drainage.
4. Follow up: Participants will be reviewed in the outpatient clinic 2 weeks after completing the testing. Data collected at this time point will only include any adverse events that may occur following the testing period. There will be no further scheduled study follow up visits following this.
The pre- and post-drainage parameters will be collected and compared to identify the key factors and mechanisms that correlate with symptom improvement. The pleural drainage procedure will be performed as part of standard clinical care and is not an intervention of the study.
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Intervention code [1]
295055
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Not applicable
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Comparator / control treatment
All participants will serve as their own control. The post-drainage parameter will be compared to the pre-drainage parameter in the same patient.
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Control group
Active
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Outcomes
Primary outcome [1]
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Change in severity of breathlessness following drainage of pleural effusion.
Instruments:
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.
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Assessment method [1]
298654
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Timepoint [1]
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Assessments will be performed immediately pre-drainage of the pleural effusion and repeated 24-48 hours post-drainage.
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Secondary outcome [1]
325001
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Change in functional impairment at rest and during exercise following drainage of pleural effusion.
Instruments: 6-minute walk test. The distance walked, (i.e. 6MWD) will be expressed as an absolute distance (m) and as a percentage of the patient’s predicted 6MWD derived from a reference equation developed locally in healthy individuals.
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Assessment method [1]
325001
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Timepoint [1]
325001
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Assessments will be performed immediately pre-drainage of the pleural effusion and repeated 24-48 hours post-drainage.
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Secondary outcome [2]
325002
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Changes in lung physiology following drainage of pleural effusion.
Instruments: Detailed lung function including spirometry, lung volumes and gas transfer measurements will be performed as per the American Thoracic Society recommendations, provided that there are no contra-indications.
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Assessment method [2]
325002
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Timepoint [2]
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Measurements will be made during tidal and inspiratory capacity breaths performed immediately pre-drainage of the pleural effusion and repeated 24-48 hours post-drainage.
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Secondary outcome [3]
325003
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Changes in diaphragmatic morphology and function following drainage of pleural effusion.
Instruments: Pleural ultrasound will be employed to assess a) diaphragm i) shape - normal (domed), flattened or inverted; and ii) movement - the zone of apposition (Zapp) of the diaphragm at the costo-phrenic angle will be measured.
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Assessment method [3]
325003
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Timepoint [3]
325003
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Assessments will be performed immediately pre-drainage of the pleural effusion and repeated 24-48 hours post-drainage.
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Secondary outcome [4]
325004
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Changes in intra-pleural pressure during pleural effusion drainage.
Instruments: Digital manometer [Compass, Mirador Biomedical, Inc, Seattle, USA]
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Assessment method [4]
325004
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Timepoint [4]
325004
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In a subgroup of patients, end-inspiratory and end-expiratory pleural pressure measurements will be recorded at opening pressure, after every 100mL of drainage up to 1000mLs and at closing pressure.
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
Recruitment of 150 participants over a period of 24 months at a single centre based at Sir Charles Gairdner Hospital, Perth. Following on a recent internal audit, this enrolment target will be sufficient to capture effusions of varying sizes, chronicity and etiology (e.g. malignant, heart failure, hepatic hydrothorax). The sample size for this study was based on standard regression modelling strategies and is deemed sufficient given the number of predictors to be considered in the modelling.
Descriptive statistics of baseline characteristics of patients and measured responses will be provided. The magnitude and direction of the change pre- to post-drainage for the measured responses of breathlessness (VAS and Dyspnoea-12) and functional capacity (6-minute walk test) will be estimated using mean differences with 95% confidence intervals provided. Formal statistical modelling will take two approaches in order to (i) predict breathlessness response and (ii) model the mechanistic relationships between the changes in measurements pre to post procedure. Predicting breathlessness will be carried out using multiple linear regression to model the change in breathlessness and logistic regression, with ROC curve analyses, to model the dichotomous response of whether a clinically important change in breathlessness has been achieved. The analysis will investigate the impact of baseline measurements of numerous variables, including clinical data, lung physiology and measurements of diaphragmatic morphology and function along with demographics, thus enabling a prognostic index to be generated in order to identify patients and patient characteristics that would predict a positive outcome post effusion drainage. To model the mechanistic relationships between the change in measurements pre to post procedure, correlations and multiple linear regression analyses will be used to describe associations between the changes in the aforementioned variables along with changes in breathlessness variables, pleural effusion characteristics, diaphragmatic morphology and the total volume and duration of pleural drainage.
Whilst it is expected the missing data will be minimal, standard imputation techniques will be utilized if necessary, with regression analyses adjusted accordingly.
All data will be analysed using the R environment for statistical computing.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
10/02/2015
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Date of last participant enrolment
Anticipated
31/12/2016
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
150
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
5993
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment postcode(s) [1]
13418
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6009 - Nedlands
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Funding & Sponsors
Funding source category [1]
293839
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Charities/Societies/Foundations
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Name [1]
293839
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Cancer Council of Western Australia
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Address [1]
293839
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420 Bagot Road
Subiaco WA 6008
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Country [1]
293839
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Australia
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Funding source category [2]
293884
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Hospital
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Name [2]
293884
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Sir Charles Gairdner Research Advisory Group
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Address [2]
293884
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Research Advisory Committee, Department of Research,
Level 2, A Block, Sir Charles Gairdner Hospital
Hospital Ave, Nedlands, Western Australia 6009
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Country [2]
293884
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Australia
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Primary sponsor type
Individual
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Name
Professor YC Gary Lee
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Address
School of Medicine, University of Western Australia, 533 Harry Perkins Building, QE II Medical Centre, Perth, WA 6009, Australia
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Country
Australia
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Secondary sponsor category [1]
292673
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Individual
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Name [1]
292673
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Dr Rajesh Thomas
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Address [1]
292673
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Pleural Medicine Unit, Institute for Respiratory Health
Level 1, B Block, Sir Charles Gairdner Hospital
Hospital Ave, Nedlands, Western Australia 6009
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Country [1]
292673
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Australia
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Secondary sponsor category [2]
292674
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Individual
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Name [2]
292674
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Dr Maree Azzopardi
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Address [2]
292674
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Pleural Medicine Unit, Institute for Respiratory Health
Level 1, B Block, Sir Charles Gairdner Hospital
Hospital Ave, Nedlands, Western Australia 6009
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Country [2]
292674
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Australia
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Secondary sponsor category [3]
292675
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Individual
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Name [3]
292675
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Dr Sanjeevan MURUGANANDAN
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Address [3]
292675
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Pleural Medicine Unit, Institute for Respiratory Health
Level 1, B Block, Sir Charles Gairdner Hospital
Hospital Ave, Nedlands, Western Australia 6009
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Country [3]
292675
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
295281
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Sir Charles Gairdner Group Human Research Ethics Committee
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Ethics committee address [1]
295281
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Level 2, A Block, Hospital Avenue, NEDLANDS WA 6009
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Ethics committee country [1]
295281
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Australia
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Date submitted for ethics approval [1]
295281
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Approval date [1]
295281
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19/06/2014
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Ethics approval number [1]
295281
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2014-079
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Summary
Brief summary
Introduction:
Pleural effusion is a common clinical problem that can complicate many medical conditions. Breathlessness is the most common symptom of pleural effusion of any cause and the commonest reason for pleural drainage. However, improvement in breathlessness following drainage of the effusion is variable, with some patients experiencing either no benefit or worsening of their symptoms. The physiological mechanisms underpinning breathlessness in pleural effusion patients are complex and likely multi-factorial, with patient and effusion-related factors likely contributing. Comprehensively studying the physiological and symptom responses to pleural effusion drainage will provide a better understanding of the condition and could potentially identify predictors of benefit from drainage. The ability to identify those patients, whose breathlessness will improve from pleural fluid drainage from those who will not, will help avoid unnecessary pleural drainage procedures and their associated morbidities and cost. The PLeural Effusion and Symptom Evaluation (PLEASE) study will be the first prospective study to comprehensively evaluate the factors contributing to pleural effusion-related breathlessness.
Methods and analysis:
The PLEASE study is a single centre prospective study of 150 patients with symptomatic pleural effusions that require therapeutic drainage. The study aims to identify key factors that underlie breathlessness in pleural effusion patients and develop predictors of improvement in breathlessness following effusion drainage. Participants will undergo evaluation pre- and post-effusion drainage to assess functional impairment at rest and during exercise, respiratory and other physiological responses and respiratory muscle mechanics. Pre- and post-drainage parameters will be collected and compared to identify the key factors and mechanisms that correlate with symptom improvement.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof YC Gary Lee
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Address
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School of Medicine, UWA, 533 Harry Perkins Building, QE II Medical Centre, Perth, WA 6009, Australia.
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Country
66718
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Australia
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Phone
66718
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+61 410542490
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Fax
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+61 8 93462816.
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Email
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[email protected]
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Contact person for public queries
Name
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Prof YC Gary Lee
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Address
66719
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School of Medicine, UWA, 533 Harry Perkins Building, QE II Medical Centre, Perth, WA 6009, Australia.
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Country
66719
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Australia
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Phone
66719
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+61 8 9346 1754
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Fax
66719
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+61 8 9346 1555
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Email
66719
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[email protected]
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Contact person for scientific queries
Name
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Prof YC Gary Lee
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Address
66720
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School of Medicine, UWA, 533 Harry Perkins Building, QE II Medical Centre, Perth, WA 6009, Australia.
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Country
66720
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Australia
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Phone
66720
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+61 8 9346 1754
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Fax
66720
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+61 8 9346 1555
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Email
66720
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
The pleural effusion and symptom evaluation (PLEASE) study of breathlessness in patients with a symptomatic pleural effusion.
2020
https://dx.doi.org/10.1183/13993003.00980-2019
Embase
Protocol of the PLeural Effusion and Symptom Evaluation (PLEASE) study on the pathophysiology of breathlessness in patients with symptomatic pleural effusions.
2016
https://dx.doi.org/10.1136/bmjopen-2016-013213
N.B. These documents automatically identified may not have been verified by the study sponsor.
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