KingVision Video Laryngoscopy vs Direct Laryngoscopy - Equivalence Trial

Ann & Robert H Lurie Children's Hospital of Chicago

Status: Completed

Conditions: Tracheal Intubation

Treatments: Device: Ambu KingVision Video Laryngoscope aBlade; Device: Miller Direct Laryngoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02590237

2015-304

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: Under 2 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients at Lurie Children's Hospital undergoing surgery/procedure where intubation is indicated
• American Society of Anesthesiology Class I-III patients

Exclusion criteria

• Children with an expected difficult airway
• A bleeding or blood clotting disorder

Trial design

200 participants in 2 patient groups

Direct Laryngoscopy

Active Comparator group

Description:

The trachea will be intubated via direct laryngoscopy using a traditional straight blade (Miller) laryngoscope.

Treatment:

Device: Miller Direct Laryngoscopy

KingVision Video Laryngoscope

Experimental group

Description:

The trachea will be intubated using the Ambu KingVision Video Laryngoscope size 1 pediatric blade.

Treatment:

Device: Ambu KingVision Video Laryngoscope aBlade