Supraglottic Airway Devices in Pediatric Difficult Airway Situations

Not Applicable

Completed

• Conditions: Airway Morbidity; Emergencies
• Interventions: Device: Combitube, Easytube, Laryngeal masks

• Registration Number: NCT02572232
• Lead Sponsor: Medical University of Vienna

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.

Study Timeline

• Study First Submitted: 2015-10-06
• Study First Submitted QC: 2015-10-07
• Study First Posted: 2015-10-08
• Study Start: 2016-09-01
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-15
• Last Update Posted: 2018-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• pediatricians
• residents
• interns
• written informed consent form

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Exclusion Criteria

• none

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Time to successful ventilation	1 min

Secondary Outcome Measures

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