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The Yield of Laryngeal Ultrasound in the Diagnosis of Laryngomalacia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2013 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01991964
First Posted: November 25, 2013
Last Update Posted: November 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
  Purpose

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 Intervention
Stridor Laryngomalacia Other: laryngeal ultrasound

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

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

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

Estimated Enrollment: 40
Study Start Date: December 2013
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
No Contacts or Locations Provided
  More Information

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01991964     History of Changes
Other Study ID Numbers: TASMC-13-FS-0563-13-CTIL
First Submitted: November 18, 2013
First Posted: November 25, 2013
Last Update Posted: November 25, 2013
Last Verified: November 2013

Keywords provided by Tel-Aviv Sourasky Medical Center:
stridor
laryngomalacia
ultrasound

Additional relevant MeSH terms:
Laryngomalacia
Respiratory Sounds
Cartilage Diseases
Musculoskeletal Diseases
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities
Connective Tissue Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms