The Yield of Laryngeal Ultrasound in the Diagnosis of Laryngomalacia

Study Overview
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Brief Summary
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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.

Official Title
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The Yield of Laryngeal Ultrasound in the Diagnosis of Laryngomalacia

Conditions
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Stridor, Laryngomalacia

Intervention / Treatment
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* Other: laryngeal ultrasound


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: laryngeal ultrasound stridor<br>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. | Other: laryngeal ultrasound<br> <br> |
| Other: laryngeal ultrasound -control<br>Infants matched for age referred for flexible bronchoscopy for reasons other than stridor will undergo an awake US of the larynx. | Other: laryngeal ultrasound<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The yield of US in diagnosing laryngomalacia in comparison to FLB. |  | December 2013- January 2015 (13 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The yield of US in diagnosing other causes of congenital stridor compared to FLB. |  | December 2013- January 2015 (13 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stridor, laryngomalacia, ultrasound