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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.
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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.
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Secondary ID [1]
313936
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None
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Universal Trial Number (UTN)
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Trial acronym
PneumoFOT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pneumothorax
336631
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Primary spontaneous pneumothorax
336632
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Secondary spontaneous pneumothorax
336633
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Iatrogenic pneumothorax
336634
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Traumatic pnuemothorax
336635
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Condition category
Condition code
Respiratory
333133
333133
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
330585
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Diagnosis / Prognosis
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Feasibility of conducting FOT in patients with all causes of pneumothorax.
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Assessment method [1]
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Feasibility assessed by screening and recruitment rate. Feasibility refers to the viability of conducting FOT in patients with pneumothorax. Primary focus is on screening, recruitment, and acceptability record. We will maintain detailed records of the recruitment process, including the number of patients screened, reasons for non-eligibility, and any challenges faced during recruitment. We will record the number of patients who agree to and complete the FOT. We will also record the patient discomfort level by asking participants to complete a five-point Likert scale. The scale ranges from 1 to 5, with 1 indicating ‘no’ on discomfort scale and 5 indicating ‘severe discomfort’. No - 1, Very mild - 2, Mild - 3, Moderate - 4, Severe - 5.
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Timepoint [1]
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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.
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Primary outcome [2]
340804
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Acceptability to perform FOT.
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Assessment method [2]
340804
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Patient discomfort score - Likert scale (No - 1, Very mild - 2, Mild - 3, Moderate - 4, Severe - 5)
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Timepoint [2]
340804
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The final assessment is when the lungs are expanded or up to 3 months of follow-up, whichever is earlier.
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Secondary outcome [1]
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Composite end point: Safety and adverse events.
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Assessment method [1]
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All adverse events are recorded and reported to Data and Safety Management Board (DSMB). The severity definitions are mentioned below 1. Mild – Transient or mild discomfort; no limitation in activity; no medical intervention/therapy required. 2. Moderate - Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention/therapy required. 3. Severe – Marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalizations possible. 4. Life threatening – Extreme limitation in activity, significant assistance required; significant medical intervention/therapy required hospitalization or hospice care probable. A Serious Adverse Event (SAE) Any untoward medical occurrence that: • results in death, • is life-threatening, • requires inpatient hospitalization or prolongation of existing hospitalization, • results in persistent or significant disability/incapacity CAUSALITY Definitions Causality should be assessed against the AE that prompted the report. An event is considered to have a causal relationship if there is a reasonable possibility that it may be related to the intervention. 1. Unrelated - There is no evidence of any causal relationship. 2. Unlikely to be related. There is little evidence to suggest there is a causal relationship (e.g. the event did not occur within a reasonable time after administration of the trial IMP/novel device/intervention). There is another reasonable explanation for the event (e.g. the patient’s clinical condition, or other concomitant treatment). 3. Possibly related - There is some evidence to suggest a causal relationship (e.g. the event occurred within a reasonable time after administration of the trial IMP/novel device/intervention). However, the influence of other factors may have contributed to the event (e.g. the patient’s clinical condition, or other concomitant treatment). 4. Probably related - There is evidence to suggest a causal relationship, and the influence of other factors is unlikely. 5. Definitely related - There is clear evidence to suggest a causal relationship, and other possible contributing factors can be ruled out. The adverse events are collected from the patient medical records during follow-ups.
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Timepoint [1]
444798
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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
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Secondary outcome [2]
445110
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Symptom score.
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Assessment method [2]
445110
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Visual analogue score for breathlessness and pain. A 10 cm line with two end points representing extremes of symptoms.
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Timepoint [2]
445110
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Recorded during every FOT measured and final assessment at the end of study at 3 months or at lung expansion, whichever is early.
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Secondary outcome [3]
445111
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Chest x-ray scoring of pneumothorax.
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Assessment method [3]
445111
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Collin's method and ImageJ software.
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Timepoint [3]
445111
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Recorded for all participants and assessed at the end of the study at 3 months or at lung expansion, whichever is early.
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Secondary outcome [4]
445379
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Follow-up rate
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Assessment method [4]
445379
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The number of patients who remain in the study through to completion, including attending follow-up visits, will be recorded. The study will assess and analyse why patients may drop out or lose to follow-up.
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Timepoint [4]
445379
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At the end of study completion. Three months or at lung expansion, which ever is earlier.
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Eligibility
Key inclusion criteria
Adult (>/= 18 years) in and out-patients referred for assessment of a new diagnosis of all causes of pneumothorax.
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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
• 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.
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/04/2025
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Actual
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Date of last participant enrolment
Anticipated
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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
40
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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]
27614
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment postcode(s) [1]
43787
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6009 - Nedlands
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Funding & Sponsors
Funding source category [1]
318422
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Charities/Societies/Foundations
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Name [1]
318422
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Institute of respiratory health
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Address [1]
318422
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Country [1]
318422
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Australia
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Primary sponsor type
Charities/Societies/Foundations
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Name
Institute of respiratory health
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Address
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Country
Australia
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Secondary sponsor category [1]
320821
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None
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Name [1]
320821
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Address [1]
320821
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Country [1]
320821
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
317049
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Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee
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Ethics committee address [1]
317049
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https://www.scgh.health.wa.gov.au/Research/Department-of-Research/My-Project/HREC
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Ethics committee country [1]
317049
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Australia
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Date submitted for ethics approval [1]
317049
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29/11/2024
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Approval date [1]
317049
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05/02/2025
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Ethics approval number [1]
317049
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Summary
Brief summary
Pneumothorax, commonly called a collapsed lung, occurs when air leaks out of the lung and accumulates between the lung and the chest wall. This condition can affect individuals with healthy lungs and those with underlying conditions such as emphysema. It can also result from trauma or complications from procedures like lung biopsies. Patients with pneumothorax may remain asymptomatic or have trouble breathing due to the collapsed lung, reduced lung capacity from underlying diseases, or interference with diaphragm function caused by the accumulated air. The exact cause of these symptoms can sometimes be unclear. Treatment may involve inserting a chest tube between the ribs to remove the air and reinflate the lung, which helps alleviate symptoms. Currently, no formal lung function assessments are specifically for patients with pneumothorax. Traditional lung function tests, such as spirometry, require forceful breathing manoeuvres and are contraindicated in patients with pneumothorax as they can exacerbate the air-leak and increase symptoms. The Forced Oscillation Technique (FOT) assesses the mechanical function of the airways and lungs without requiring patient effort. Patients can breathe at rest, while FOT measures the mechanical properties of the lungs. FOT is safe in infants, pregnant women and in sick patients admitted to the intensive care unit. This pilot study aimed to explore the feasibility of performing FOT in patients with pneumothorax and provide insights into the respiratory mechanics of the lungs in pneumothorax. We will correlate FOT parameters with patient symptoms and radiological findings and evaluate if FOT can be a surrogate method to monitor pneumothorax recovery.
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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
139826
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Prof Y C Gary Lee
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Address
139826
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UWA School of Medicine 533 Harry Perkins Building QE II Medical Centre Perth WA 6009
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Country
139826
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Australia
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Phone
139826
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+61 861510913
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Fax
139826
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Email
139826
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[email protected]
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Contact person for public queries
Name
139827
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Niranjan Ananda Setty
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Address
139827
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Respiratory physician, Sir Charles Gairdner Hospital, B block, Perth WA 6009
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Country
139827
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Australia
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Phone
139827
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+61412825712
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Fax
139827
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Email
139827
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[email protected]
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Contact person for scientific queries
Name
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Niranjan Ananda Setty
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Address
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Respiratory physician, Sir Charles Gairdner Hospital, B block, Perth WA 6009
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Country
139828
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Australia
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Phone
139828
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+61412825712
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Fax
139828
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Email
139828
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
24523
Ethical approval
12554_2502051537_WA Health Central Human Research Ethics Committee (EC00481)_Ethics Approved - HREC.pdf
24524
Informed consent form
PICF PneumoFOT V1.1 05.02.2025 clean.doc
24525
Study protocol
PneumoFOT protocol V1.1 05.02.2025 clean.docx
24578
Informed consent form
PICF PneumoFOT V2 28.02.2025 clean.doc
24579
Study 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.
Download to PDF