- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01991964
The Yield of Laryngeal Ultrasound in the Diagnosis of Laryngomalacia
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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 -control
Infants matched for age referred for flexible bronchoscopy for reasons other than stridor will undergo an awake US of the larynx.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The yield of US in diagnosing laryngomalacia in comparison to FLB.
Time Frame: December 2013- January 2015 (13 months)
|
December 2013- January 2015 (13 months)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The yield of US in diagnosing other causes of congenital stridor compared to FLB.
Time Frame: December 2013- January 2015 (13 months)
|
December 2013- January 2015 (13 months)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TASMC-13-FS-0563-13-CTIL
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