The Yield of Laryngeal Ultrasound in the Evaluation of Stridor and Dysphonia in Children

Sponsor

Tel-Aviv Sourasky Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT02244697

Collaborator

(none)

100

Enrollment

Location

Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Stridor Vocal Cord Paralysis

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Crossover

Time Perspective:

Prospective

Official Title:

The Yield of Laryngeal Ultrasound in the Evaluation of Stridor and Dysphonia in Children

Study Start Date :

Sep 1, 2014

Anticipated Primary Completion Date :

Apr 1, 2016

Anticipated Study Completion Date :

Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: laryngeal ultrasound stridor 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.
Other: laryngeal ultrasound -control Infants matched for age referred for ANL for reasons other than stridor will undergo US of the larynx.

Outcome Measures

Primary Outcome Measures

The number of participants that will be diagnosed with anatomical and functional causes of stridor and dysphonia by US in comparisom with ANL [2014-2016]
i.e. vocal cord nodules, vocal cord paralysis, vocal cord cyst etc.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.