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

About this trial
This is an interventional treatment trial for Airway Morbidity
Eligibility Criteria
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
NCT ID
NCT02572232
First Posted
October 6, 2015
Last Updated
August 15, 2018
Sponsor
Medical University of Vienna
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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