The Yield of Laryngeal Ultrasound in the Diagnosis of Laryngomalacia

• Sponsor: Tel-Aviv Sourasky Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01991964
• Collaborator: (none)
• Enrollment: 40
• Arms: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stridor; Laryngomalacia	Other: laryngeal ultrasound	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: The Yield of Laryngeal Ultrasound in the Diagnosis of Laryngomalacia
• Study Start Date: Dec 1, 2013
• Anticipated Primary Completion Date: Jan 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The yield of US in diagnosing laryngomalacia in comparison to FLB. [December 2013- January 2015 (13 months)]

Secondary Outcome Measures

1. The yield of US in diagnosing other causes of congenital stridor compared to FLB. [December 2013- January 2015 (13 months)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 12 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Tel-Aviv Sourasky Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tel-Aviv Sourasky Medical Center
• ClinicalTrials.gov Identifier: NCT01991964
• Other Study ID Numbers: TASMC-13-FS-0563-13-CTIL
• First Posted: Nov 25, 2013
• Last Update Posted: Nov 25, 2013
• Last Verified: Nov 1, 2013

• Keywords provided by Tel-Aviv Sourasky Medical Center: stridor; laryngomalacia; ultrasound
• Additional relevant MeSH terms: Laryngomalacia; Respiratory Sounds

Study Results

No Results Posted as of Nov 25, 2013