Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001124729
Ethics application status
Approved
Date submitted
8/08/2022
Date registered
16/08/2022
Date last updated
2/09/2022
Date data sharing statement initially provided
16/08/2022
Date results information initially provided
16/08/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Computerized Tomography (CT) Larynx for diagnosis of Vocal Cord Dysfunction
Scientific title
Computerized Tomography (CT) Larynx for diagnosis of Vocal Cord Dysfunction, a comparison to laryngoscopy
Secondary ID [1] 307722 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vocal Cord Dysfunction 327289 0
Condition category
Condition code
Respiratory 324420 324420 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Computed Tomography larynx and laryngoscopy are both conducted to assess for vocal cord dysfunction. There are no contrast dyes administered, this is a non-contrast scan. The anticipated duration of this CT is 10-15 minutes and laryngoscopy is done over 10-15 minutes.

The CT Larynx is conducted and assessed by the radiologist and the laryngoscopy is done by the ENT practitioner. Both procedures are done once.
Intervention code [1] 324197 0
Diagnosis / Prognosis
Comparator / control treatment
Both CT larynx and Laryngoscopy are done to assess for VCD. The CT is compared to the gold-standard which is laryngoscopy.

CT larynx as well as the laryngoscopy are done either within one hour or on separate days, This was done to examine temporal concordance (within an hour) and to compare testing on separate occasions.
Control group
Active

Outcomes
Primary outcome [1] 332232 0
Comparison of the accuracy of CT larynx versus laryngoscopy. Sensitivity and specificity of CT larynx calculated relative to gold-standard (laryngoscopy) Sensitivity and specificity be analysed together as a composite outcome.
Timepoint [1] 332232 0
Within one hour of assessment
Secondary outcome [1] 412652 0
Positive and negative predictive values based on estimated prevalence of VCD in the cohorts of 30%, 10% and 50%. False positive value also calculated.

Positive and negative predictive values will be derived from the primary outcome data (sensitivity and specificity). This secondary outcome is dependent on prevalence of VCD in the cohorts and estimates of 30%, 10% and 50% will be presented. False positive values will also be calculated from the primary outcome data.
Timepoint [1] 412652 0
Comparisons made based on findings in two case series:
- Patients compared having testing within one hour.
- Patients compared having testing on separate days.

Eligibility
Key inclusion criteria
Patients with suspected vocal cord dysfunction assessed by computed tomography larynx and laryngoscopy as part of standard care.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No clinical suspicion of vocal cord dysfunction.
Other explanation for symptoms.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data analyses will be conducted to assess concordance between the tests. Laryngoscopy is used as the gold standard for case definition and compared to CT larynx. Sensitivity, specificity, positive predictive values, negative predictive values and falso positive rates will be calculated. Inter-rater reliability will be examined using Cohen’s Kappa and all statistical analyses will be conducted using SPSS.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/05/2018
Date of last participant enrolment
Anticipated
Actual
30/07/2021
Date of last data collection
Anticipated
Actual
30/07/2021
Sample size
Target
28
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22924 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 38230 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 311995 0
Hospital
Name [1] 311995 0
Monash Health Lung and Sleep Institute
Country [1] 311995 0
Australia
Funding source category [2] 312171 0
Government body
Name [2] 312171 0
NH&MRC
Country [2] 312171 0
Australia
Primary sponsor type
Hospital
Name
Monash Lung Sleep Allergy & Immunology
Address
Monash Medical Centre Clayton
246 Clayton Road, 3168 Clayton, Victoria
Country
Australia
Secondary sponsor category [1] 313488 0
None
Name [1] 313488 0
Address [1] 313488 0
Country [1] 313488 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311417 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 311417 0
Monash Medical Centre
246 Clayton Road, 3168 Clayton, Victoria
Ethics committee country [1] 311417 0
Australia
Date submitted for ethics approval [1] 311417 0
Approval date [1] 311417 0
01/01/2016
Ethics approval number [1] 311417 0
Monash Health Ref: RES-18-0000-084L

Summary
Brief summary
Vocal cord dysfunction/inducible laryngeal obstruction (VCD/ILO) is common but seldom recognised at first since patients experience intermittent breathlessness leading in most cases to a diagnosis of asthma and treatment with inhaled corticosteroids (CS). Diagnosis of VCD/ILO is further complicated by coexistence of asthma and VCD/ILO in 20-40% of asthmatics and VCD/ILO can make asthma seem more severe leading to over-treatment with high-dose inhaled or oral CS. To date a swift diagnosis is seldom achieved.
The current gold-standard for diagnosis of VCD/ILO is laryngoscopy and the quintessential abnormality is inspiratory closure of the vocal cords and formation of a diamond-shaped small opening or ‘chink’ posteriorly. Laryngoscopy requires expertise that may not be available within a reasonable time-frame and the procedure can be technically challenging or fail if a patient is breathless and distressed. Consequently, laryngoscopy may be delayed or not performed.
Laryngoscopy in expert hands remains the definitive diagnostic modality but innovations in diagnostic imaging have created alternative options. Present-day imaging technologies with superior spatial and temporal resolution have made it possible to visualise not only anatomical features, but also movement and function of a particular organ. We have developed dynamic CT larynx to detect and quantify laryngeal movement, a technology that can be applied wherever cardiac CT is performed.
We hypothesised that dynamic CT larynx would have comparable diagnostic accuracy to laryngoscopy in VCD/ILO, when performed contemporaneously and when utilised in a real-world clinical context.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121022 0
Prof Philip Bardin
Address 121022 0
Monash Health Lung Sleep Allergy & immunology, 246 Clayton Rd, Clayton VIC 3168
Country 121022 0
Australia
Phone 121022 0
+61 395942281
Fax 121022 0
Email 121022 0
philip.bardin@monash.edu
Contact person for public queries
Name 121023 0
Prof Philip Bardin
Address 121023 0
Monash Health Lung Sleep Allergy & immunology, 246 Clayton Rd, Clayton VIC 3168
Country 121023 0
Australia
Phone 121023 0
+61 395942281
Fax 121023 0
Email 121023 0
philip.bardin@monash.edu
Contact person for scientific queries
Name 121024 0
Prof Philip Bardin
Address 121024 0
Monash Health Lung Sleep Allergy & immunology, 246 Clayton Rd, Clayton VIC 3168
Country 121024 0
Australia
Phone 121024 0
+61 395942281
Fax 121024 0
Email 121024 0
philip.bardin@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified data, individual participant data underlying published results only
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
Case-by-case basis at the discretion of Primary Investigator.
Available for what types of analyses?
To achieve the aims in the approved proposal.
How or where can data be obtained?
Access subject to approval by Principal Investigator: philip.bardin@monash.edu


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17080Study protocol  philip.bardin@monash.edu
17081Statistical analysis plan  philip.bardin@monash.edu



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.