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

September 16, 2014 updated by: Tel-Aviv Sourasky Medical Center

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Tel-Aviv, Israel
        • Sourasky Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Investigators

  • Principal Investigator: Shirley Friedman, Doctor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

April 1, 2016

Study Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

September 2, 2014

First Submitted That Met QC Criteria

September 16, 2014

First Posted (Estimate)

September 19, 2014

Study Record Updates

Last Update Posted (Estimate)

September 19, 2014

Last Update Submitted That Met QC Criteria

September 16, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TASMC-14-FS-0191-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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