The Yield of Laryngeal Ultrasound in the Diagnosis of Laryngomalacia

Not Applicable

• Conditions: Stridor; Laryngomalacia
• Interventions: Other: laryngeal ultrasound

• Registration Number: NCT01991964
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

The hypothesis of the study is that laryngeal US can accurately and reliably diagnose laryngomalacia in infants with congenital stridor.

Stridor is a respiratory noise caused by partial obstruction of the large airways at the level of the pharynx, larynx and/or trachea. The most prevalent congenital cause of stridor is laryngomalacia. Flexible laryngobronchoscopy (FLB) under sedation is regarded as the gold standard. However, FLB under sedation has some drawbacks as it requires venous access, use of sedative agents, may cause discomfort for the patient and is costly.

Ultrasound (US) is a noninvasive, painless, radiation free, well tolerated imaging technique. It allows for dynamic assessment of moving structures in an awake patient and the results can be easily displayed and recorded.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-11
• Study First Submitted: 2013-11-18
• Study First Submitted QC: 2013-11-21
• Last Update Submitted: 2013-11-21
• Study First Posted: 2013-11-25
• Last Update Posted: 2013-11-25
• Study Start: 2013-12
• Primary Completion: 2015-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Infants referred for FLB and bronchoscopy due to congenital stridor at the Department of Pediatric Pulmonology, Critical Care and Sleep Medicine at the Tel Aviv Sourasky Medical Centre

Exclusion Criteria

• Prior knowledge of the cause for stridor
• History of foreign body aspiration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
laryngeal ultrasound stridor	laryngeal ultrasound	During the study period, infants referred for FLB and bronchoscopy due to congenital stridor at the Department of Pediatric Pulmonology, Critical Care and Sleep Medicine at the Tel Aviv Sourasky Medical Centre will undergo an awake US of the larynx prior to performing the Flexible bronchoscopy.
laryngeal ultrasound -control	laryngeal ultrasound	Infants matched for age referred for flexible bronchoscopy for reasons other than stridor will undergo an awake US of the larynx.

Primary Outcome Measures

Name	Time	Method
The yield of US in diagnosing laryngomalacia in comparison to FLB.	December 2013- January 2015 (13 months)

Secondary Outcome Measures

Name	Time	Method
The yield of US in diagnosing other causes of congenital stridor compared to FLB.	December 2013- January 2015 (13 months)