Supraglottic Airway Devices in Pediatric Difficult Airway Situations

NCT ID: NCT02572232

Last Updated: 2018-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-01
• Study Completion Date: 2017-12-31

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.

Conditions

Airway Morbidity; Emergencies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combitube, Easytube, Laryngeal masks

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

Group Type: EXPERIMENTAL

Combitube, Easytube, Laryngeal masks

Intervention Type: DEVICE

Supraglottic airway device

Interventions

Combitube, Easytube, Laryngeal masks

Supraglottic airway device

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• pediatricians
• residents
• interns
• written informed consent form

Exclusion Criteria

• none

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Michael Frass

Univ.Prof.Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Frass, Prof. Dr.

Role: STUDY_CHAIR

Medical University of Vienna

Other Identifiers

1805/2015

Identifier Type: -

Identifier Source: org_study_id