NCT04836338

GlideScope Spectrum Video Laryngoscope Blades and Stylet for Use in Neonate & Pre-Adolescent Populations

Assessment of the GlideScope Spectrum Video Laryngoscope Blades and Stylet for Use in Neonate & Pre-Adolescent Populations: Pilot Manikin Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Verathon · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The overall purpose of this study is to assess the functionality \& impact of the use of the newly designed GlideScope Spectrum pediatric video laryngoscope and stylet for the orotracheal intubation of neonates and pediatric patients, utilizing manikin models.

Detailed description

The overall purpose of this study is to assess the functionality \& impact of the use of the newly designed GlideScope Spectrum pediatric video laryngoscope blades and stylet for the orotracheal intubation of neonates and pediatric patients, utilizing manikin models. The hypothesis is that the Spectrum laryngoscope blades and stylet can improve the time and/or success of orotracheal intubation in a manikin. Secondary aims of this study include assessing the impact of Spectrum pediatric video laryngoscope blades under simulated normal and difficult airway conditions on glottic view grade, mouth space, ease of blade insertion, ease of tracheal tube insertion, mechanisms of tracheal tube insertion impediment, and perceived overall clinical \& functional usefulness in airways with predictors of difficult intubation.

Conditions

• Pediatric ALL

Interventions

Type	Name	Description
DEVICE	orotracheal intubation	orotracheal intubation

Timeline

• Start date: 2016-01-21
• Primary completion: 2016-02-09
• Completion: 2020-10-01
• First posted: 2021-04-08
• Last updated: 2021-04-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study