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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000235404
Ethics application status
Approved
Date submitted
10/02/2025
Date registered
31/03/2025
Date last updated
31/03/2025
Date data sharing statement initially provided
31/03/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study to assess a lung function tests as a monitoring tool in patients with pneumothorax.
Scientific title
The PnuemoFOT study: a pilot feasibility study to explore assessment of respiratory mechanics using Forced Oscillation Technique (FOT) in patients with all causes of pneumothorax.
Secondary ID [1] 313936 0
None
Universal Trial Number (UTN)
Trial acronym
PneumoFOT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pneumothorax 336631 0
Primary spontaneous pneumothorax 336632 0
Secondary spontaneous pneumothorax 336633 0
Iatrogenic pneumothorax 336634 0
Traumatic pnuemothorax 336635 0
Condition category
Condition code
Respiratory 333133 333133 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
PneumoFOT study is a feasibility study to assess if Forced Oscillation Technique (FOT) can be done in patients with all causes of pneumothorax. This study will enrol 40 consecutive patients with pneumothorax who presents to Sir Charles Gairdner Hospital (SCGH), Perth, Western Australia. The patients may be in-patient, out-patients or individuals who visit emergency services at SCGH. The inclusion criteria are all adult (>/= 18 years) in and out-patients referred for assessment of a new diagnosis of all causes of pneumothorax.

The FOT machine is owned by the Department of Respiratory medicine, Airways unit and does not need additional charges. The FOT machine is manufactured by Thorasys medical system inc based in Montreal, Canada.

FOT machine is a simple handheld portable device that delivers different frequency sound waves through the mouthpiece to the respiratory system. The frequency of assessment includes starting from 5 hertz to 35 hertz. The final assessment includes the parameters of impedance of the lung, which includes the resistance(R) of airways at 5hz and high frequency (20 hertz) and reactance (x) at both high and low frequencies. We will also measure the resonant frequency (Fres) and the area of reactance (the area under X5 till the resonant frequency).

The FOT is usually conducted by the researcher Dr Niranjan Ananda Setty, in his absence the staff will be trained to conduct FOT. A training log will be maintained. The adherence will be monitored by direct observation and the recordings of the FOT, which will be saved in the safe folder.

The assessment will include the following parameters:
1. At baseline (day 0) - baseline characteristics including medical history, Visual Analogue Scale for breathlessness and pain, chest x-ray findings, and FOT readings.

Patient baseline characteristics recorded included age, sex, height, weight, smoking status, pack-years, co-morbid illnesses like asthma, COPD, bronchiectasis, interstitial lung disease, and cause of pneumothorax. Vital signs of all patients, including heart rate, SpO2, and blood pressure, will be routinely recorded.

2. Once discharged then in an out-patient setting - symptom assessment VAS for breathlessness and pain, chest x-ray findings, and FOT readings recorded at their follow-up appointments as clinically indicated by the treating team.

3. In-patient setting - symptom assessment including VAS score for breathlessness and pain, chest x-ray, and FOT readings recorded regularly until discharge.

4. The final assessment is when the lungs are expanded or up to 3 months of follow-up, whichever is earlier.

FOT is a simple non-invasive lung function assessment. It involves 2-3 minutes of breathing through a small machine at rest. All patients will have their FOT parameters assessed. Resistance (R) at different frequencies, Reactance (Xrs) and the pattern of FOT recordings will be recorded.

Chest x-ray is a routine way monitoring pneumothorax. The size of pneumothorax are calculated using Collins method and ImageJ software.

The patient will be enrolled if the treating physician deems it safe to proceed. All consenting patients will be monitored during FOT measurement. Vital signs, including respiratory rate, pulse rate, blood pressure, and oxygen saturation (SpO2), will be closely monitored during and after FOT


Intervention code [1] 330585 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340687 0
Feasibility of conducting FOT in patients with all causes of pneumothorax.
Timepoint [1] 340687 0
Screening and recruitment assessed at the conclusion of the project. The final assessment is when the lungs are expanded or up to 3 months of follow-up, whichever is earlier.
Primary outcome [2] 340804 0
Acceptability to perform FOT.
Timepoint [2] 340804 0
The final assessment is when the lungs are expanded or up to 3 months of follow-up, whichever is earlier.
Secondary outcome [1] 444798 0
Composite end point: Safety and adverse events.
Timepoint [1] 444798 0
These adverse events are assessed at the end of the study. If it is an SAE, the DSMB will be informed and actioned accordingly. The adverse events are assessed as and when it is recorded and at the end of study at 3 months or at lung expansion, whichever is early
Secondary outcome [2] 445110 0
Symptom score.
Timepoint [2] 445110 0
Recorded during every FOT measured and final assessment at the end of study at 3 months or at lung expansion, whichever is early.
Secondary outcome [3] 445111 0
Chest x-ray scoring of pneumothorax.
Timepoint [3] 445111 0
Recorded for all participants and assessed at the end of the study at 3 months or at lung expansion, whichever is early.
Secondary outcome [4] 445379 0
Follow-up rate
Timepoint [4] 445379 0
At the end of study completion. Three months or at lung expansion, which ever is earlier.

Eligibility
Key inclusion criteria
Adult (>/= 18 years) in and out-patients referred for assessment of a new diagnosis of all causes of pneumothorax.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Hemodynamically unstable on non-invasive ventilation or mechanical ventilation or requiring face mask oxygen.
• Significant breathlessness leading to inability to speak in full sentences.
• Age <18 years
• Pregnancy/lactation
• Inability to consent and/or comply with protocol.

Study design
Purpose of the study
Educational / counselling / training
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
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 27614 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 43787 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 318422 0
Charities/Societies/Foundations
Name [1] 318422 0
Institute of respiratory health
Country [1] 318422 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Institute of respiratory health
Address
Country
Australia
Secondary sponsor category [1] 320821 0
None
Name [1] 320821 0
Address [1] 320821 0
Country [1] 320821 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317049 0
Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee
Ethics committee address [1] 317049 0
Ethics committee country [1] 317049 0
Australia
Date submitted for ethics approval [1] 317049 0
29/11/2024
Approval date [1] 317049 0
05/02/2025
Ethics approval number [1] 317049 0

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

Contacts
Principal investigator
Name 139826 0
Prof Y C Gary Lee
Address 139826 0
UWA School of Medicine 533 Harry Perkins Building QE II Medical Centre Perth WA 6009
Country 139826 0
Australia
Phone 139826 0
+61 861510913
Fax 139826 0
Email 139826 0
Contact person for public queries
Name 139827 0
Niranjan Ananda Setty
Address 139827 0
Respiratory physician, Sir Charles Gairdner Hospital, B block, Perth WA 6009
Country 139827 0
Australia
Phone 139827 0
+61412825712
Fax 139827 0
Email 139827 0
Contact person for scientific queries
Name 139828 0
Niranjan Ananda Setty
Address 139828 0
Respiratory physician, Sir Charles Gairdner Hospital, B block, Perth WA 6009
Country 139828 0
Australia
Phone 139828 0
+61412825712
Fax 139828 0
Email 139828 0

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24523Ethical approval    12554_2502051537_WA Health Central Human Research Ethics Committee (EC00481)_Ethics Approved - HREC.pdf
24524Informed consent form    PICF PneumoFOT V1.1 05.02.2025 clean.doc
24525Study protocol    PneumoFOT protocol V1.1 05.02.2025 clean.docx
24578Informed consent form    PICF PneumoFOT V2 28.02.2025 clean.doc
24579Study protocol    PneumoFOT protocol V2 28.02.2025 clean.docx



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.