ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

PLEASE-3

Linked study record

Health condition

Health condition(s) or problem(s) studied:

pleural effusion

Condition category

Condition code

Respiratory

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]

Diagnosis / Prognosis

Comparator / control treatment

No controls

Control group

Uncontrolled

Outcomes

Primary outcome [1]

The predictive value of bendopnea in relief of breathlessness as assessed using a visual analogue scale after pleural fluid drainage.

Timepoint [1]

Participants will be assessed at baseline and then followed up within 36 hours following pleural effusion drainage

Secondary outcome [1]

Functional capacity as assessed with a 6-minute walk test, 6MWT

Timepoint [1]

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?

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

Final

Recruitment in Australia

Recruitment state(s)

NSW,WA

Recruitment hospital [1]

Sir Charles Gairdner Hospital - Nedlands

Recruitment hospital [2]

Westmead Hospital - Westmead

Recruitment postcode(s) [1]

6009 - Nedlands

Recruitment postcode(s) [2]

2145 - Westmead

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Charlies Foundation for Research Mid Range Grant

Address [1]

Sir Charles Gairdner Hospital,
Hospital Avenue,
Nedlands 6009 WA

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee

Ethics committee address [1]

Sir Charles Gairdner Hospital
2nd Floor A Block
Hospital Avenue 
NEDLANDS Western Australia 6009

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/02/2022

Approval date [1]

11/05/2022

Ethics approval number [1]

Summary

Brief summary

Pleural effusions (excess fluid accumulation between the lung and chest wall) affect 60,000 Australians every year and can arise from a wide range of causes including cancer, heart and liver failure. Pleural effusions often cause disabling breathlessness. Drainage of the fluid (usually requires inserting tubes between the ribs) can relieve symptoms, but the benefits vary among patients. The mechanism by which pleural effusion causes breathlessness remains unclear. A reliable method of identifying the patients likely to respond to drainage may help reduce unnecessary, painful procedures and their associated complications and healthcare costs. The PLeural Effusion And Symptom Evaluation project aims address this knowledge gap. 
Bendopnoea (breathlessness on bending forward) is a common clinical complaint in patients with pleural effusion but has not been previously studied.  Our pilot data found that bendopnoea was significantly associated with the presence of pleural effusion.  
The PLEASE-3 study will aim to evaluate the value of bendopnoea as a screening test for effusion-related breathlessness, its predictive value of symptomatic benefits from fluid drainage and explore the physiological mechanisms underlying bendopnoea.
Participation on this study involves completing questionnaires, performing a bendopnoea test, breathing test via spirometry and a 6-Minute walk test. If there is fluid needed to be drained first, the tests will be performed once before and once after the fluid is drained (within 36 hours of removal of the fluid). The results of these 2 sets will be compared to each other to find out the difference, if any, of removing the fluid.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof YC Gary Lee

Address

533, Harry Perkins Research Building,
QE II Med Ctr,
6 Verdun Street,
Nedlands, WA 6009

Country

Australia

Phone

+61 8 61510913

Fax

gary.lee@uwa.edu.au

Contact person for public queries

Name

YC Gary Lee

Address

533, Harry Perkins Research Building,
QE II Med Ctr,
6 Verdun Street,
Nedlands, WA 6009

Country

Australia

Phone

+61 8 61510913

Fax

gary.lee@uwa.edu.au

Contact person for scientific queries

Name

YC Gary Lee

Address

533, Harry Perkins Research Building,
QE II Med Ctr,
6 Verdun Street,
Nedlands, WA 6009

Country

Australia

Phone

+61 8 61510913

Fax

gary.lee@uwa.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Email
15204	Study protocol	calvinjit.sidhu@health.wa.gov.au
15205	Statistical analysis plan	calvinjit.sidhu@health.wa.gov.au
15206	Informed consent form	calvinjit.sidhu@health.wa.gov.au
15207	Clinical study report	calvinjit.sidhu@health.wa.gov.au
15208	Ethical approval	calvinjit.sidhu@health.wa.gov.au
15209	Analytic code	calvinjit.sidhu@health.wa.gov.au

Results publications and other study-related documents

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Documents added automatically

No additional documents have been identified.

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