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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.

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]

None

Universal Trial Number (UTN)

Trial acronym

PneumoFOT

Linked study record

Health condition

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

Pneumothorax

Primary spontaneous pneumothorax

Secondary spontaneous pneumothorax

Iatrogenic pneumothorax

Traumatic pnuemothorax

Condition category

Condition code

Respiratory

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]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Feasibility of conducting FOT in patients with all causes of pneumothorax.

Timepoint [1]

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]

Acceptability to perform FOT.

Timepoint [2]

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

Secondary outcome [1]

Composite end point: Safety and adverse events.

Assessment method [1]

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.

Timepoint [1]

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]

Symptom score.

Timepoint [2]

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]

Chest x-ray scoring of pneumothorax.

Timepoint [3]

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]

Follow-up rate

Timepoint [4]

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?

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

1/04/2025

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)

Recruitment hospital [1]

Sir Charles Gairdner Hospital - Nedlands

Recruitment postcode(s) [1]

6009 - Nedlands

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Institute of respiratory health

Address [1]

Country [1]

Australia

Primary sponsor type

Charities/Societies/Foundations

Name

Institute of respiratory health

Address

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]

https://www.scgh.health.wa.gov.au/Research/Department-of-Research/My-Project/HREC

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/11/2024

Approval date [1]

05/02/2025

Ethics approval number [1]

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Y C Gary Lee

Address

UWA School of Medicine 533 Harry Perkins Building QE II Medical Centre Perth WA 6009

Country

Australia

Phone

+61 861510913

Fax

[email protected]

Contact person for public queries

Name

Niranjan Ananda Setty

Address

Respiratory physician, Sir Charles Gairdner Hospital, B block, Perth WA 6009

Country

Australia

Phone

+61412825712

Fax

[email protected]

Contact person for scientific queries

Name

Niranjan Ananda Setty

Address

Respiratory physician, Sir Charles Gairdner Hospital, B block, Perth WA 6009

Country

Australia

Phone

+61412825712

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	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.

Trial Review

Documents added manually

Documents added automatically