Supraglottic Airway Devices in Pediatric Difficult Airway Situations

Emergencies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02572232
• Other study ID #: 1805/2015
• Status: Completed
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: December 2017

Study information

• Verified date: August 2018
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• pediatricians

• residents

• interns

• written informed consent form

Exclusion Criteria:

Related Conditions & MeSH terms

• Airway Morbidity
• Emergencies

Intervention

Device:
• Combitube, Easytube, Laryngeal masks
Supraglottic airway device

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to successful ventilation		1 min
Secondary	Success rate		1 min
Secondary	Rating of the device (questionnaire)	questionnaire, ratings from 1 (best) to 5 (worst)	1 min
Secondary	Re-assessment of success rate after 3 months		3 months
Secondary	Re-assessment of time to successful ventilation after 3 months		3 months