The Yield of Laryngeal Ultrasound in the Diagnosis of Laryngomalacia

NCT01991964 | Unknown

• 1 other identifier: TASMC-13-FS-0563-13-CTIL
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stridor; Laryngomalacia

Keywords

stridor; laryngomalacia; ultrasound

Outcome Measures

Primary Outcomes (1)

• The yield of US in diagnosing laryngomalacia in comparison to FLB.

  December 2013- January 2015 (13 months)

Secondary Outcomes (1)

• The yield of US in diagnosing other causes of congenital stridor compared to FLB.

  December 2013- January 2015 (13 months)

Study Arms (2)

laryngeal ultrasound stridor

EXPERIMENTAL

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

laryngeal ultrasound -control

OTHER

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

Other: laryngeal ultrasound

Interventions

laryngeal ultrasound OTHER

laryngeal ultrasound -control; laryngeal ultrasound stridor

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Prior knowledge of the cause for stridor
• History of foreign body aspiration

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

MeSH Terms

Conditions

Respiratory Sounds; Laryngomalacia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cartilage Diseases; Musculoskeletal Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: November 25, 2013
• Study Start: December 1, 2013
• Primary Completion: January 1, 2015
• Last Updated: November 25, 2013

Record last verified: 2013-11