ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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

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

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Vocal Cord Dysfunction

Condition category

Condition code

Respiratory

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]

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]

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]

Within one hour of assessment

Secondary outcome [1]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Monash Medical Centre - Clayton campus - Clayton

Recruitment postcode(s) [1]

3168 - Clayton

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Monash Health Lung and Sleep Institute

Address [1]

Monash Medical Centre Clayton
246 Clayton Road, 3168 Clayton, Victoria

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

NH&MRC

Address [2]

16 Marcus Clarke St, Canberra ACT 2601

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash Health Human Research Ethics Committee

Ethics committee address [1]

Monash Medical Centre
246 Clayton Road, 3168 Clayton, Victoria

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

01/01/2016

Ethics approval number [1]

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

Prof Philip Bardin

Address

Monash Health Lung Sleep Allergy & immunology, 246 Clayton Rd, Clayton VIC 3168

Country

Australia

Phone

+61 395942281

Fax

philip.bardin@monash.edu

Contact person for public queries

Name

Philip Bardin

Address

Monash Health Lung Sleep Allergy & immunology, 246 Clayton Rd, Clayton VIC 3168

Country

Australia

Phone

+61 395942281

Fax

philip.bardin@monash.edu

Contact person for scientific queries

Name

Philip Bardin

Address

Monash Health Lung Sleep Allergy & immunology, 246 Clayton Rd, Clayton VIC 3168

Country

Australia

Phone

+61 395942281

Fax

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.	Type	Citation	Link	Email	Other Details	Attachment
17080	Study protocol			philip.bardin@monash.edu
17081	Statistical 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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically