Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001109695
Ethics application status
Approved
Date submitted
20/09/2023
Date registered
24/10/2023
Date last updated
23/06/2024
Date data sharing statement initially provided
24/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The Pneumothorax And Symptom Evaluation (PASE) Study: Bendopnoea in patients with pneumothorax
Scientific title
The Pneumothorax And Symptom Evaluation (PASE) Study: Bendopnoea in patients with pneumothorax
Secondary ID [1] 310643 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PASE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pneumothorax 331526 0
Condition category
Condition code
Respiratory 328264 328264 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will undergo the below assessments once at baseline, and in those patients who receive air drainage/lung re-inflation as per standard care and treating physician, they will repeat the below assessments one more time post lung re-inflation. Air drainage and lung re-inflation is at the discretion of the treating physician and is not a trial related intervention. The delegated study team will undertake and administer all the below assessments. All assessments will take approximately 20-25 minutes in total.

1. Bendopnoea test. The patient is sitting in a chair and is instructed to bend forward at the waist and aim to touch his/her ankles and maintain this position for up to 60 seconds. Patient will inform the investigator as soon as breathlessness bending forward (i.e., bendopnoea) occurs, The test will end as soon as symptom onset. Patients will be instructed to inform the staff member if they feel dizzy or lightheaded, and if so the test will be ceased.

2. Bendopnoea questionnaire. In a qualitative manner with the following question:
“Since the onset of your symptoms, how has shortness of breath when bending forward impacted your day-to-day activities?”
i. No limitation: I was not troubled by breathlessness when bending forward
ii. Mild: I felt breathless when bending forward and performing an 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 wished 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 air drainage procedure, the question will be phrased: “since the procedure, how does shortness of breath when bending forward impact your day-to-day activities?”


3. Breathlessness questionnaire (Visual Analogue Scale). Breathlessness will be measured using a 100mm visual analogue scale (VAS) anchored by “no shortness of breath at all” and “maximum shortness of breath”. The mean of the VAS scores measured by two independent researchers will be documented.

4. Pain questionnaire (Visual Analogue Scale). Pain will be measured using a 100mm visual analogue scale (VAS) anchored by “no pain” and “worst pain”. The mean of the VAS scores measured by two independent researchers will be documented.

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 pneumothorax will be recorded.

Pneumothorax Characteristics The size of the pneumothorax will be measured on standard erect PA inspiration chest radiographs (CXR) with the Light Index and Collins Method. The Light Index measures the average diameter of the lung and the hemithorax, cubing these diameters, and finding the rations whereas the Collins Method calculates the ‘sum of interpleural distances’ which estimates the pneumothorax size.
Intervention code [1] 327045 0
Early detection / Screening
Comparator / control treatment
Nil.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336142 0
Incidence of bendopnoea in patients with pneumothorax
Timepoint [1] 336142 0
1. At baseline (pre drainage/lung reinflation) and,
2. For those proceeding to drainage (as per standard care and treating physician), within 10 days after the drain is removed.
Secondary outcome [1] 427053 0
Degree of overall breathlessness
Timepoint [1] 427053 0
1. At baseline (pre drainage/lung reinflation) and,
2. For those proceeding to drainage (as per standard care and treating physician), within 10 days after the drain is removed.
Secondary outcome [2] 427614 0
Degree of chest pain
Timepoint [2] 427614 0
1. At baseline (pre drainage/lung reinflation) and,
2. For those proceeding to drainage (as per standard care and treating physician), within 10 days after the drain is removed.

Eligibility
Key inclusion criteria
In- and out-patients referred for assessment of a unilateral spontaneous (primary or secondary) pneumothorax or iatrogenic pneumothorax.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Pneumothorax with a concurrent pleural effusion > 1cm in size
• Hemodynamically unstable (systolic blood pressure of <90 mmHg, heart rate in beats per minute greater than or equal to systolic blood pressure in mmHg, respiratory rate of >30 breaths per minute, and Spo2 of <90% on room air)
• 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 of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2023
Actual
16/04/2024
Date of last participant enrolment
Anticipated
1/12/2025
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
50
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 314859 0
Other
Name [1] 314859 0
Institute for Respiratory Health
Country [1] 314859 0
Australia
Primary sponsor type
Other
Name
Institute for Respiratory Health
Address
Level 2/6 Verdun St, Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 316869 0
None
Name [1] 316869 0
Address [1] 316869 0
Country [1] 316869 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313858 0
Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee
Ethics committee address [1] 313858 0
Sir Charles Gairdner Hospital 2nd Floor A Block Hospital Avenue NEDLANDS Western Australia 6009
Ethics committee country [1] 313858 0
Australia
Date submitted for ethics approval [1] 313858 0
28/09/2023
Approval date [1] 313858 0
18/12/2023
Ethics approval number [1] 313858 0
RGS0000006354

Summary
Brief summary
Pneumothorax (collapsed lung) occurs when air leaks from the lung and accumulates between the chest wall and lung. The mechanism of breathlessness in pneumothorax is unclear, and symptoms vary between patients. Sometimes tubes need to be inserted between the ribs to drain the collected air and help the lung reinflate, and occasionally surgery is required. Currently, the effect of accumulated air in the pleural space and its association with diaphragmatic function and symptoms of breathlessness is not understood. Bendopnoea (breathlessness when bending forward) is an
evolving clinical symptom that has been demonstrated as clinically useful in some heart and lung conditions. Whether bendopnoea is present in patients with pneumothorax, and its potential clinical usefulness has not yet been investigated. The PASE study is a pilot study to explore the incidence and clinical relevance of bendopnoea in patients with pneumothorax and may provide better understanding of breathlessness in pneumothorax.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129582 0
Prof Y C Gary lee
Address 129582 0
Institute for Respiratory Health, Level 5, 6 Verdun St, Nedlands WA 6009
Country 129582 0
Australia
Phone 129582 0
+61 410542490
Fax 129582 0
Email 129582 0
gary.lee@uwa.edu.au
Contact person for public queries
Name 129583 0
Prof Y C Gary lee
Address 129583 0
Institute for Respiratory Health, Level 5, 6 Verdun St, Nedlands WA 6009
Country 129583 0
Australia
Phone 129583 0
+61 410542490
Fax 129583 0
Email 129583 0
gary.lee@uwa.edu.au
Contact person for scientific queries
Name 129584 0
Prof Y C Gary lee
Address 129584 0
Institute for Respiratory Health, Level 5, 6 Verdun St, Nedlands WA 6009
Country 129584 0
Australia
Phone 129584 0
+61 410542490
Fax 129584 0
Email 129584 0
gary.lee@uwa.edu.au

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
20440Study protocol    386631-(Uploaded-20-09-2023-17-15-07)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.