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Supraglottic Airway Devices in Pediatric Difficult Airway Situations

Primary Purpose

Airway Morbidity, Emergencies

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Combitube, Easytube, Laryngeal masks
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Airway Morbidity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • pediatricians
  • residents
  • interns
  • written informed consent form

Exclusion Criteria:

  • none

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Combitube, Easytube, Laryngeal masks

    Arm Description

    Combitube, Easytube, Laryngeal mask airway are intubated in pediatric airway manikins by probands in randomized order.

    Outcomes

    Primary Outcome Measures

    Time to successful ventilation

    Secondary Outcome Measures

    Success rate
    Rating of the device (questionnaire)
    questionnaire, ratings from 1 (best) to 5 (worst)
    Re-assessment of success rate after 3 months
    Re-assessment of time to successful ventilation after 3 months

    Full Information

    First Posted
    October 6, 2015
    Last Updated
    August 15, 2018
    Sponsor
    Medical University of Vienna
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02572232
    Brief Title
    Supraglottic Airway Devices in Pediatric Difficult Airway Situations
    Official Title
    Comparison of Three Different Supraglottic Airway Devices and Endotracheal Intubation in Pediatric Difficult Airway Situations in a Manikin
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2016 (Actual)
    Primary Completion Date
    December 2017 (Actual)
    Study Completion Date
    December 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical University of Vienna

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of the study is to compare three supraglottic airway devices (Combitube, Easytube, laryngeal mask airway) to endotracheal intubation in a simulated difficult airway scenario in a pediatric manikin.
    Detailed Description
    Supraglottic airway devices (SAD) have been designed for the "cannot intubate, cannot ventilate" scenario in prehospital as well as intrahospital settings and are utilized in medical emergency services and emergency departments all over the world, not only for anticipated and unanticipated difficult airway situations but also as an airway device used by non-anesthesiologists or in situations where only limited practice is possible. Securing an airway in a pediatric emergency situation is crucial. Unfortunately, pediatricians usually lack the required skills and regular practice to perform endotracheal intubation (ETI, which is the gold standard for securing an airway) quickly and safely. SADs would pose a safe and feasible alternative to ETI. However, no studies on this topic are available. The investigators therefore wanted to evaluate three different SADs (Combitube, Easytube, laryngeal mask airway) in simulated difficult airway situations in a pediatric manikin in comparison to ETI.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Airway Morbidity, Emergencies

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Combitube, Easytube, Laryngeal masks
    Arm Type
    Experimental
    Arm Description
    Combitube, Easytube, Laryngeal mask airway are intubated in pediatric airway manikins by probands in randomized order.
    Intervention Type
    Device
    Intervention Name(s)
    Combitube, Easytube, Laryngeal masks
    Intervention Description
    Supraglottic airway device
    Primary Outcome Measure Information:
    Title
    Time to successful ventilation
    Time Frame
    1 min
    Secondary Outcome Measure Information:
    Title
    Success rate
    Time Frame
    1 min
    Title
    Rating of the device (questionnaire)
    Description
    questionnaire, ratings from 1 (best) to 5 (worst)
    Time Frame
    1 min
    Title
    Re-assessment of success rate after 3 months
    Time Frame
    3 months
    Title
    Re-assessment of time to successful ventilation after 3 months
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: pediatricians residents interns written informed consent form Exclusion Criteria: none
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael Frass, Prof. Dr.
    Organizational Affiliation
    Medical University of Vienna
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Supraglottic Airway Devices in Pediatric Difficult Airway Situations

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