NCT02590237

KingVision Video Laryngoscopy vs Direct Laryngoscopy - Equivalence Trial

A Clinical Evaluation of the King Vision Video Laryngoscope aBlade System in Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether the Ambu KingVision videolaryngoscope performs as well as direct laryngoscopy for intubating small children and infants.

Detailed description

The goal of this prospective randomized study is to compare the Ambu KingVision Video Laryngoscope and direct laryngoscopy using the Miller Blade Laryngoscope. The primary outcome of the study will be time to successful intubation. Other outcomes of clinical relevance such as first attempt success rates of intubation, grade of laryngeal view, percentage of glottic opening, number of insertion attempts, hemodynamic responses, and complications will also be assessed.

Conditions

• Tracheal Intubation

Interventions

Type	Name	Description
DEVICE	Ambu KingVision Video Laryngoscope aBlade	At time of tracheal intubation, the subject will be intubated using the Ambu KingVision Video Laryngoscope with a size 1 aBlade. The first attempt to successful intubation will be assessed. The Cormack Lehane and Percentage of Glottic Opening scores will be recorded. Information on time to glottic view, time to removal of the blade, and time of first capnography upstroke (successful intubation) will be recorded. Other parameters measured will be information on subsequent attempts, ease of tracheal tube insertion, and hemodynamic responses for 5 minutes.
DEVICE	Miller Direct Laryngoscopy	At time of tracheal intubation, the subject will be intubated using a Miller blade laryngoscope. The first attempt to successful intubation will be assessed. The Cormack Lehane and Percentage of Glottic Opening scores will be recorded. Information on time to glottic view, time to removal of the blade, and time of first capnography upstroke (successful intubation) will be recorded. Other parameters measured will be information on subsequent attempts, ease of tracheal tube insertion, and hemodynamic responses for 5 minutes.

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2015-10-28
• Last updated: 2016-10-03

Locations

1 site across 1 country: United States