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The Yield of Laryngeal Ultrasound in the Diagnosis of Laryngomalacia

Primary Purpose

Stridor, Laryngomalacia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
laryngeal ultrasound
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stridor focused on measuring stridor, laryngomalacia, ultrasound

Eligibility Criteria

undefined - 12 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    laryngeal ultrasound stridor

    laryngeal ultrasound -control

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    November 18, 2013
    Last Updated
    November 21, 2013
    Sponsor
    Tel-Aviv Sourasky Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01991964
    Brief Title
    The Yield of Laryngeal Ultrasound in the Diagnosis of Laryngomalacia
    Official Title
    The Yield of Laryngeal Ultrasound in the Diagnosis of Laryngomalacia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2013
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2013 (undefined)
    Primary Completion Date
    January 2015 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tel-Aviv Sourasky Medical Center

    4. Oversight

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stridor, Laryngomalacia
    Keywords
    stridor, laryngomalacia, ultrasound

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    laryngeal ultrasound stridor
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    laryngeal ultrasound -control
    Arm Type
    Other
    Arm Description
    Infants matched for age referred for flexible bronchoscopy for reasons other than stridor will undergo an awake US of the larynx.
    Intervention Type
    Other
    Intervention Name(s)
    laryngeal ultrasound
    Primary Outcome Measure Information:
    Title
    The yield of US in diagnosing laryngomalacia in comparison to FLB.
    Time Frame
    December 2013- January 2015 (13 months)
    Secondary Outcome Measure Information:
    Title
    The yield of US in diagnosing other causes of congenital stridor compared to FLB.
    Time Frame
    December 2013- January 2015 (13 months)

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    12 Months
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Learn more about this trial

    The Yield of Laryngeal Ultrasound in the Diagnosis of Laryngomalacia

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