Computerized Tomography (CT) Larynx for diagnosis of Vocal Cord Dysfunctio

Not Applicable

Completed

• Conditions: Vocal Cord Dysfunction; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12622001124729
• Lead Sponsor: Monash Lung Sleep Allergy & Immunology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-07-30
• Study Start: 2022-08-16
• Last Update Posted: 12 September 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Patients with suspected vocal cord dysfunction assessed by computed tomography larynx and laryngoscopy as part of standard care.

Exclusion Criteria

No clinical suspicion of vocal cord dysfunction.
Other explanation for symptoms.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.[Within one hour of assessment]

Secondary Outcome Measures

Name	Time	Method
Positive and negative predictive values based on estimated prevalence of VCD in the cohorts of 30%, 10% and 50%. False positive value also calculated. <br><br>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.[Comparisons made based on findings in two case series:<br>- Patients compared having testing within one hour.<br>- Patients compared having testing on separate days.]