Clinical Trial: The Yield of Laryngeal Ultrasound in the Diagnosis of Laryngomalacia

Study Status: Withdrawn
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary:
Sponsor: Tel-Aviv Sourasky Medical Center

Current Primary Outcome: The yield of US in diagnosing laryngomalacia in comparison to FLB. [ Time Frame: December 2013- January 2015 (13 months) ]

Original Primary Outcome: Same as current

Current Secondary Outcome: The yield of US in diagnosing other causes of congenital stridor compared to FLB. [ Time Frame: December 2013- January 2015 (13 months) ]

Original Secondary Outcome: Same as current

Information By: Tel-Aviv Sourasky Medical Center

Dates:
Date Received: November 18, 2013
Date Started: December 2013
Date Completion:
Last Updated: November 21, 2013
Last Verified: November 2013