Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001199303p
Ethics application status
Help: Ethics application status
Submitted, not yet approved
Date submitted
Help: Date submitted
3/09/2026
Date registered
Help: Date registered
28/09/2026
Date last updated
Help: Date last updated
28/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
28/09/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing a new light-based lung imaging test to standard clinical bronchoscopy for the assessment of collapsing windpipes in children and their outcomes over 12 months
Scientific title
Direct assessment of cartilage malformations using bronchoscopic polarization-sensitive optical coherence tomography (PS-OCT): correlating novel imaging findings with clinical bronchoscopy diagnoses
Additional trial identifiers [1] 318281 0
Nil known
Universal Trial Number (UTN)
Trial acronym
QWIK (Quick Windpipe Imaging for Kids)
Related trial records

Health condition
Health condition(s) studied:
tracheomalacia 343395 0
tracheobronchomalacia 343396 0
Condition category
Condition code
Respiratory 339480 339480 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of the intervention or exposure
Name of exposure: PS-OCT airway imaging during bronchoscopy

Infants and children (all-comers) undergoing clinically indicated bronchoscopy at Perth Children's Hospital (Perth, WA, Australia) are recruited to this study. Following standard clinical assessment, some participants may receive a diagnosis of tracheomalacia or bronchomalacia, while others may receive alternative diagnoses or no diagnosis of airway malacia. Immediately following completion of the clinically indicated bronchoscopy assessment and during the same procedure, participants will undergo research imaging of their trachea and main bronchi. This adds a maximum of 5 minutes to the bronchoscopy duration. Imaging is performed using an endoscopic laser-based imaging technology called polarisation-sensitive optical coherence tomography (PS-OCT). PS-OCT outcomes include measures of airway cartilage and dynamic airway collapse. The endoscopic imaging probe is encased in a 1 mm (outer diameter) transparent, single-use, sterile, distally sealed plastic sheath. The probe is passed through the bronchoscope's working channel, under the bronchoscopist's direct visualisation and control. The probe is operated and controlled by the bronchoscopist, while a trained PS-OCT operator (biomedical engineer or similar) operates the data acquisition. The PS-OCT research device is not registered with the TGA, and a CTN will be established for the study.

PS-OCT imaging results are not used for clinical decision-making, diagnosis, or participant management, which are determined entirely independently via standard clinical assessment. The imaging is performed for research purposes only. Clinical diagnoses are determined independently by the treating clinical team using standard clinical assessment, bronchoscopy findings, and CT imaging where available. PS-OCT-derived cartilage measurements and airway collapse measurements will be correlated with independently determined clinical diagnoses, standard bronchoscopy findings, and dynamic airway collapse assessments. 12-month follow-up data capturing symptoms, medication use and hospital resource use (ED visits and admissions) will be collected via 3-monthly questionnaires. PS-OCT outcomes will be analysed against these longitudinal data.

Frequency and duration of observation: PS-OCT imaging occurs once, for a maximum of 5 minutes, immediately following completion of the clinically indicated bronchoscopy assessment and during the same procedure. Follow-up observation via questionnaire occurs 3-monthly for 12 months following the procedure.
Intervention code [1] 335239 0
Diagnosis / Prognosis
Description of the comparator or control
No control group. This is an observational, correlational study with no formally assigned comparator or control arm. Participants who do not receive a tracheomalacia diagnosis provide a natural comparison within the observed cohort. Relevant participant characteristics and comorbidities, including prematurity, chronic lung disease, congenital airway abnormalities and congenital heart disease, will be recorded and considered when interpreting the study findings.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 346757 0
Composite PS-OCT airway cartilage measurements, including cartilage-to-posterior-membrane ratio measured within the trachea and main bronchi.
Timepoint [1] 346757 0
Single timepoint, during the clinically-indicated bronchoscopy. This timepoint is referred to as baseline.
Secondary outcome [1] 467363 0
Respiratory symptoms
Timepoint [1] 467363 0
Following clinically-indicated bronchoscopy (baseline), 3, 6, 9 and 12 months post-bronchoscopy.
Secondary outcome [2] 467364 0
Dynamic expiratory airway collapse (measured as percent of cross sectional area, %CSA)
Timepoint [2] 467364 0
Single-time point, as part of the clinically-indicated bronchoscopy. Baseline.
Secondary outcome [3] 468201 0
Respiratory medication use
Timepoint [3] 468201 0
Following clinically-indicated bronchoscopy (baseline), 3, 6, 9 and 12 months post-bronchoscopy.
Secondary outcome [4] 468202 0
Emergency department presentations
Timepoint [4] 468202 0
Following clinically-indicated bronchoscopy (baseline), 3, 6, 9 and 12 months post-bronchoscopy.
Secondary outcome [5] 468571 0
Hospital admissions
Timepoint [5] 468571 0
Following clinically-indicated bronchoscopy (baseline), 3, 6, 9 and 12 months post-bronchoscopy.

Eligibility
Key inclusion criteria
• Informed consent by either the child and/or parent/guardian, as appropriate.
• Age between 0-18 years
• Male and female
• With and without suspected or confirmed tracheomalacia or bronchomalacia (malacia of the main bronchi)
• Undergoing clinically indicated bronchoscopy for purposes unrelated to this research study such as persistent wet cough.

Participants will not withhold any medication or any treatment for the purpose of this study.
Minimum age
No limit
Maximum age
18 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
• Refusal of informed consent.
• Language difficulties or inability to read or do questionnaires.
• Pregnancy or the possibility of pregnancy (as indicated by answering “yes” to the question “Is it possible that you are / your child is pregnant?”).
• Participants will be excluded where extending the bronchoscopy by 5 minutes and introducing PS-OCT imaging probe for the research project is not deemed appropriate by anaesthetist or bronchoscopist.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sample size is feasibility-determined (60 participants), giving 80% power (alpha=0.05) to detect moderate effects (r=~0.35, d=~0.77) in primary and secondary analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2026
Actual
Date of last participant enrolment
Anticipated
1/12/2028
Actual
Date of last data collection
Anticipated
1/12/2029
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 30145 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 46541 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 322837 0
Charities/Societies/Foundations
Name [1] 322837 0
BrightSpark Foundation
Country [1] 322837 0
Australia
Funding source category [2] 322912 0
University
Name [2] 322912 0
The University of Western Australia
Country [2] 322912 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
Country
Australia
Secondary sponsor category [1] 325836 0
None
Name [1] 325836 0
Address [1] 325836 0
Country [1] 325836 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 321274 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 321274 0
Ethics committee country [1] 321274 0
Australia
Date submitted for ethics approval [1] 321274 0
07/05/2026
Approval date [1] 321274 0
Ethics approval number [1] 321274 0

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

Contacts
Principal investigator
Name 153214 0
Dr Michael Jona Hackmann
Address 153214 0
The University of Western Australia, 35 Stirling Highway, Crawley WA 6009
Country 153214 0
Australia
Phone 153214 0
+61 8 6488 3302
Fax 153214 0
Email 153214 0
[email protected]
Contact person for public queries
Name 153215 0
Michael Jona Hackmann
Address 153215 0
The University of Western Australia, 35 Stirling Highway, Crawley WA 6009
Country 153215 0
Australia
Phone 153215 0
+61 8 6488 3302
Fax 153215 0
Email 153215 0
[email protected]
Contact person for scientific queries
Name 153216 0
Michael Jona Hackmann
Address 153216 0
The University of Western Australia, 35 Stirling Highway, Crawley WA 6009
Country 153216 0
Australia
Phone 153216 0
+61 8 6488 3302
Fax 153216 0
Email 153216 0
[email protected]

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


What supporting documents are/will be available?

No Supporting Document Provided


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.