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

NCT02244697 | Unknown

• 1 other identifier: TASMC-14-FS-0191-CTIL
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Stridor; Vocal Cord Paralysis

Keywords

Stridor; Vocal Cord Paralysis (VCP); Ultrasound (US)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Sourasky Medical Centre

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Respiratory Sounds; Vocal Cord Paralysis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Vagus Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations

Study Officials

• Shirley Friedman, Doctor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shirley Friedman, Doctor

CONTACT

shirfri@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: September 19, 2014
• Study Start: September 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: September 19, 2014

Record last verified: 2014-09

Locations

IL (1)