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

NCT ID: NCT02244697

Last Updated: 2014-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Stridor Vocal Cord Paralysis

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Other: laryngeal ultrasound -control

Infants matched for age referred for ANL for reasons other than stridor will undergo US of the larynx.

No interventions assigned to this group

Eligibility Criteria

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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
Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shirley Friedman, Doctor

Role: PRINCIPAL_INVESTIGATOR

Locations

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Sourasky Medical Centre

Tel Aviv, , Israel

Site Status

Countries

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Israel

Central Contacts

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Shirley Friedman, Doctor

Role: CONTACT

Other Identifiers

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TASMC-14-FS-0191-CTIL

Identifier Type: -

Identifier Source: org_study_id

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