The Yield of Laryngeal Ultrasound in the Diagnosis of Laryngomalacia

Tel Aviv Sourasky Medical Center

Status: Unknown

Conditions: Stridor; Laryngomalacia

Treatments: Other: laryngeal ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT01991964

TASMC-13-FS-0563-13-CTIL

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: Under 12 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

laryngeal ultrasound stridor

Experimental group

Description:

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.

Treatment:

Other: laryngeal ultrasound

laryngeal ultrasound -control

Other group

Description:

Infants matched for age referred for flexible bronchoscopy for reasons other than stridor will undergo an awake US of the larynx.

Treatment:

Other: laryngeal ultrasound