Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-30 @ 9:40 AM
Study NCT ID:
NCT02572232
Status:
COMPLETED
Last Update Posted:
2018-08-16
First Post:
2015-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Supraglottic Airway Devices in Pediatric Difficult Airway Situations
Sponsor:
Medical University of Vienna
Organization:
Study Overview
Official Title:
Comparison of Three Different Supraglottic Airway Devices and Endotracheal Intubation in Pediatric Difficult Airway Situations in a Manikin
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: