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Clinical Trials/NCT02572232
NCT02572232
Completed
Not Applicable

Comparison of Three Different Supraglottic Airway Devices and Endotracheal Intubation in Pediatric Difficult Airway Situations in a Manikin

Medical University of Vienna0 sites40 target enrollmentSeptember 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Airway Morbidity
Sponsor
Medical University of Vienna
Enrollment
40
Primary Endpoint
Time to successful ventilation
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2016
End Date
December 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael Frass

Univ.Prof.Dr.

Medical University of Vienna

Eligibility Criteria

Inclusion Criteria

  • pediatricians
  • residents
  • written informed consent form

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Time to successful ventilation

Time Frame: 1 min

Secondary Outcomes

  • Success rate(1 min)
  • Re-assessment of success rate after 3 months(3 months)
  • Rating of the device (questionnaire)(1 min)
  • Re-assessment of time to successful ventilation after 3 months(3 months)

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