Vocal Cord Paralysis Clinical Trial
Official title:
The Yield of Laryngeal Ultrasound in the Evaluation of Stridor and Dysphonia in Children
Stridor is a respiratory noise caused by partial obstruction of the large airways at the
level of the pharynx, larynx and/or trachea. The second most common cause of stridor is
vocal cord paralysis.
Awake nasolaryngoscopyn (ANL) is regarded as the gold standard for the diagnosis of
laryngomalacia. However, ANL has some drawbacks as it may cause discomfort for the patient
and the laryngeal view may be obscured due to patient movement or anatomical variations.
Ultrasound (US) is a noninvasive, painless, radiation free, well tolerated imaging
technique. Evaluation of the dynamic characteristics of the glottis by US revealed perfect
reliability in comparison to nasolryngoscopy suggesting that US can be useful in the
assessment of laryngeal adduction.
The investigator hypothesize that laryngeal US can be an accurate and reliable adjunct in
the diagnosis of functional and anatomical causes of stridor and dysphonia in the pediatric
population.
| Status | Not yet recruiting |
| Enrollment | 100 |
| Est. completion date | April 2016 |
| Est. primary completion date | April 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 16 Years |
| Eligibility |
Inclusion Criteria: children aged 0-16 years referred for an awake nasolaryngoscopy for stridor or dysphonia at the pediatric Otolaryngology unit at the Tel Aviv Sourasky Medical Centre will undergo US of the larynx. Exclusion Criteria: |
Observational Model: Case-Crossover, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Israel | Sourasky Medical Centre | Tel-Aviv |
| Lead Sponsor | Collaborator |
|---|---|
| Tel-Aviv Sourasky Medical Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The number of participants that will be diagnosed with anatomical and functional causes of stridor and dysphonia by US in comparisom with ANL | i.e. vocal cord nodules, vocal cord paralysis, vocal cord cyst etc. | 2014-2016 | No |
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