The Yield of Laryngeal Ultrasound in the Diagnosis of Laryngomalacia

Stridor Clinical Trial

Official title:

The Yield of Laryngeal Ultrasound in the Diagnosis of Laryngomalacia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01991964
• Other study ID #: TASMC-13-FS-0563-13-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: November 18, 2013
• Last updated: November 21, 2013
• Start date: December 2013

Study information

• Verified date: November 2013
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Months

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Laryngomalacia
• Stridor

Intervention

Other:
• laryngeal ultrasound

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The yield of US in diagnosing laryngomalacia in comparison to FLB.		December 2013- January 2015 (13 months)	No
Secondary	The yield of US in diagnosing other causes of congenital stridor compared to FLB.		December 2013- January 2015 (13 months)	No