Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000465752
Ethics application status
Approved
Date submitted
24/02/2022
Date registered
24/03/2022
Date last updated
2/03/2023
Date data sharing statement initially provided
24/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Bendopnea in patients with pleural effusion
Scientific title
The Third PLeural Effusion And Symptom Evaluation (PLEASE-3) Study: Assessing the predictive value of bendopnea as a screening test in patients with pleural effusion
Secondary ID [1] 306516 0
None
Universal Trial Number (UTN)
Trial acronym
PLEASE-3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pleural effusion 325385 0
Condition category
Condition code
Respiratory 322767 322767 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The following parameters will be assessed using a range of validated tools for all patients
1. At baseline (pre-drainage) and,
2. For those proceeding to pleural fluid drainage, at 24-36 hours post drainage. For patients with intercostal catheter (ICC) or indwelling pleural catheter (IPC), this will be after the pleural fluid is completely drained.

A) Bendopnoea is assessed:
1. in a qualitative manner (as modified from Baeza-Trinidad et al) with the following question:
a. “In the last 7 days, how does shortness of breath when bending forward impact your day-to-day activities?”
i. No limitation: I was not troubled breathlessness when bending forward
ii. Mild: I felt breathless when bending forward and performing activity (e.g., tying shoelaces) but can still perform activities without limitation or rest.
iii. Moderate: I had to stop and take breaks from bending forward to complete what I wish to do (e.g. I have to bend down several times to complete tying the laces of both shoes).
iv. Severe: I was too breathless to bend forward
b. After the pleural procedure the question will be phrased: “how does shortness of breath when bending forward impact your day-to-day activity now”
2. With objective testing, as per published studies:
a. Patient sitting in a chair is instructed to bend forward at the waist and aim to touch his/her ankles and maintain this position for 60 seconds. Patient will inform the investigator as soon as breathlessness occurs, and the time of onset of bendopnoea recorded.
b. Bendopnoea is assessed:
i. As a continuous variable (time to breathlessness) and
ii. As present or absent during the test.
The semi-quantitative question and objective test in chair will be administered by a respiratory physician and it will only take 5 minutes to complete.

Degree of breathlessness and impairment on functional activities:
Breathlessness will be measured using a validated 100mm visual analog scale (VAS) anchored by “no shortness of breath at all” and “maximum shortness of breath”. VAS, has been successfully used in several of our RCTs on malignant effusion management (e.g. TIME-2, -3 and AMPLE-1) with the lower end of the 95%CI (14 mm) used as the minimum clinically important difference. The VAS scale will be provided by a respiratory physician and will only take 1 minute to complete.

The impact of breathlessness on function
This will be measured with a standard 6-minute walk test performed by trained operators as per guidelines. This is a well validated and commonly used measure.

Patient characteristics
Breathlessness can be a result of concurrent illnesses (e.g., heart failure, COPD etc) and intrathoracic (e.g., pulmonary emboli) or extrathoracic factors (e.g., muscle wasting) which will be captured from case notes. Height, weight and body mass index will be recorded. Cardio-pulmonary status (respiratory and heart rates, blood pressure and oxygen saturation) and the aetiology of the effusion will be recorded. Spirometric volumes (FEV1 and FVC) will be performed according to the American Thoracic Society criteria. This will be assessed by a respiratory physician and will take approximately 5 minutes to complete. Echocardiogram will not be requested specifically for this study; however if the patient has echocardiogram studies performed for their clinical need, the data will be recorded.

Pleural effusion characteristics
The size of the effusion will be graded semi-quantitatively on chest radiographs (CXR) using the scores (0 to 5) as published by Light et al, and as our lead investigators have used in prior publications. The volume of fluid drained and its biochemistry (protein, LDH, pH, etc) will be recorded.

Evaluation of diaphragmatic dysfunction
Pleural ultrasound (B-mode and M-mode) will be performed at the bedside by a respiratory physician to assess both hemi-diaphragms using a real-time scanner with 3.5 and 12-MHz sector transducer (as per published methods) in the upright position: to assess diaphragm shape (normal domed, flattened or inverted) and movement (normal, reduced or paradoxical). This will take approximately 5 minutes to complete.
Intervention code [1] 322943 0
Diagnosis / Prognosis
Comparator / control treatment
No controls
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330568 0
The predictive value of bendopnea in relief of breathlessness as assessed using a visual analogue scale after pleural fluid drainage.
Timepoint [1] 330568 0
Participants will be assessed at baseline and then followed up within 36 hours following pleural effusion drainage
Secondary outcome [1] 406702 0
Functional capacity as assessed with a 6-minute walk test, 6MWT
Timepoint [1] 406702 0
Participants will be assessed at baseline and then followed up within 36 hours following pleural effusion drainage

Eligibility
Key inclusion criteria
In- and out-patients with symptomatic breathlessness referred to the SCGH Pleural Service and the Respiratory Department of Westmead Hospital for assessment and/or pleural fluid drainage.
Minimum age
19 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Age <18 years
• Mechanical limitations in bending forward (e.g., spinal conditions or large abdominal mass)
• Pregnancy/lactation.
• Inability to consent and/or comply with protocol

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/06/2022
Actual
31/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 21823 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [2] 21824 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 36881 0
6009 - Nedlands
Recruitment postcode(s) [2] 36882 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 310861 0
Hospital
Name [1] 310861 0
Charlies Foundation for Research Mid Range Grant
Country [1] 310861 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Institute for Respiratory Health
Address
Level 2, 6 Verdun Street,
Nedlands 6009 WA
Country
Australia
Secondary sponsor category [1] 312118 0
None
Name [1] 312118 0
Address [1] 312118 0
Country [1] 312118 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310423 0
Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee
Ethics committee address [1] 310423 0
Ethics committee country [1] 310423 0
Australia
Date submitted for ethics approval [1] 310423 0
25/02/2022
Approval date [1] 310423 0
11/05/2022
Ethics approval number [1] 310423 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117614 0
Prof YC Gary Lee
Address 117614 0
533, Harry Perkins Research Building,
QE II Med Ctr,
6 Verdun Street,
Nedlands, WA 6009
Country 117614 0
Australia
Phone 117614 0
+61 8 61510913
Fax 117614 0
Email 117614 0
[email protected]
Contact person for public queries
Name 117615 0
YC Gary Lee
Address 117615 0
533, Harry Perkins Research Building,
QE II Med Ctr,
6 Verdun Street,
Nedlands, WA 6009
Country 117615 0
Australia
Phone 117615 0
+61 8 61510913
Fax 117615 0
Email 117615 0
[email protected]
Contact person for scientific queries
Name 117616 0
YC Gary Lee
Address 117616 0
533, Harry Perkins Research Building,
QE II Med Ctr,
6 Verdun Street,
Nedlands, WA 6009
Country 117616 0
Australia
Phone 117616 0
+61 8 61510913
Fax 117616 0
Email 117616 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15204Study protocol  [email protected]
15205Statistical analysis plan  [email protected]
15206Informed consent form  [email protected]
15207Clinical study report  [email protected]
15208Ethical approval  [email protected]
15209Analytic code  [email protected]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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