Supraglottic Airway Devices in Pediatric Difficult Airway Situations

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

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.

Study Overview

• Status: Completed
• Conditions: Emergencies; Airway Morbidity
• Intervention / Treatment: Device: Combitube, Easytube, Laryngeal masks

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• pediatricians
• residents
• interns
• written informed consent form

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combitube, Easytube, Laryngeal masks; Combitube, Easytube, Laryngeal mask airway are intubated in pediatric airway manikins by probands in randomized order.	Device: Combitube, Easytube, Laryngeal masks; Supraglottic airway device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to successful ventilation	1 min

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Study Chair: Michael Frass, Prof. Dr., Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: October 6, 2015
• First Submitted That Met QC Criteria: October 7, 2015
• First Posted (Estimate): October 8, 2015

Study Record Updates

• Last Update Posted (Actual): August 16, 2018
• Last Update Submitted That Met QC Criteria: August 15, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 1805/2015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No