Ear, Nose and Throat Respiratory
Conditions
Interventions
Ultrasound diagnosis versus Xray diagnosis.
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Adolescent and adult patients (=12 years old) referred for investigation of possible LTS based on clinical symptoms (e.g., dyspnoea, stridor, wheeze unresponsive to bronchodilators) or history (e.g., prior prolonged intubation, external neck trauma). • Patients referred for a clinically indicated CT scan of the neck/airways as part of their standard diagnostic workup. • Ability to provide written informed consent.
Exclusion criteria
Exclusion criteria: • Patients with a contraindication to CT scanning (e.g., pregnancy). • Patients with an unstable airway requiring immediate emergency intervention. • Patients with extensive neck wounds, dressings, or subcutaneous emphysema precluding adequate POCUS contact. • Prior definitive surgical treatment for LTS (e.g., laryngotracheal resection).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To determine the sensitivity and specificity of POCUS for detecting clinically significant LTS (defined as >50% luminal narrowing on CT), and to compare its overall diagnostic performance to neck XR by analyzing the Area Under the Receiver Operating Characteristic Curve (AUC-ROC). 2.To determine the sensitivity and specificity of neck XR for detecting clinically significant LTS, and to compare its overall diagnostic performance to POCUS via AUC-ROC analysis. This is a prospective, cross-sectional diagnostic test accuracy (DTA) study designed following the STARD 2015 guidelines. The primary methodological requirement is that for each participant, the index tests (POCUS and XR) and the reference standard test (CT) must be performed within 24 hours of each other. This timeframe is critical to ensure that the disease status remains unchanged between assessments. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objectives 1. To assess the agreement in stenosis grading (e.g., Myer-Cotton grade) between each index test (POCUS, XR) and the CT reference standard, using intraclass correlation coefficients (ICC) for continuous measures. 2. To evaluate the inter-observer agreement for the interpretation of POCUS and XR images between blinded clinicians, using Cohen’s Kappa (?) for categorical outcomes. 3. To analyse the technical feasibility of each index test in a resource-limited setting, reporting the proportion of indeterminate scans and the primary reasons for technical failure (e.g., poor acoustic window, patient factors). 4. To perform a subgroup analysis of the diagnostic accuracy (sensitivity, specificity) of POCUS and XR based on the anatomical location (subglottic vs. tracheal) and aetiology (post-intubation/traumatic vs. other) of the stenosis. 5. To model the clinical utility of POCUS and XR within a triage algorithm by calculating post-test probabilities based on their likelihood ratios. | — |
Countries
South Africa
Contacts
Public ContactGerhard Klopper
Walter Sisulu University
Outcome results
None listed