King Vision Video Laryngoscope aBlade vs. Direct Laryngoscopy in Children

Not Applicable

• Conditions: Tracheal Intubation
• Interventions: Device: Ambu King Vision Video Laryngoscope aBlade; Device: Direct Laryngoscopy via Miller Straight Blade

• Registration Number: NCT02384564
• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Brief Summary

The purpose of this study is to determine whether there is a clinically relevant difference in first attempt success rates between the Ambu King Vision Video Laryngoscope and Direct Laryngoscopy in Children.

Detailed Description

The goal of this prospective randomized study is to compare whether there is a clinically relevant difference in the rate of first attempt successful intubation between the Ambu King Vision Video Laryngoscope and direct laryngoscopy using the Miller Blade Laryngoscope. Other parameters of clinical relevance such as grade of laryngeal view, percentage of glottic opening, number of insertion attempts, time for successful tracheal intubation, and complications will also be assessed.

Study Timeline

• Study First Submitted: 2015-02-26
• Study First Submitted QC: 2015-03-04
• Study First Posted: 2015-03-10
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-29
• Study Start: 2015-08
• Primary Completion: 2015-10
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• ASA (American Society of Anesthesiologists) I-III classified patients
• Patients undergoing procedure where an endotracheal tube would be normally utilized

Exclusion Criteria

• Children with expected difficult airways
• Coagulopathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ambu King Vision Video Laryngoscope aBlade System	Ambu King Vision Video Laryngoscope aBlade	The trachea will be intubated using the Ambu King Vision Video Laryngoscope with the appropriate sized blade (size 1 or 2) based on manufacturer guidelines and clinical judgement.
Direct Laryngoscope	Direct Laryngoscopy via Miller Straight Blade	The trachea will be intubated via direct laryngoscopy using a traditional straight blade laryngoscope, with appropriately sized blade based on manufacturer guidelines and clinical judgement.

Primary Outcome Measures

Name	Time	Method
First Attempt Success Rate of Tracheal Intubation	Assessed intraoperatively at time of intubation	An attempt at tracheal intubation will be defined as entry of the device into the patient's mouth without the need to remove the device once entered and securing the airway.

Secondary Outcome Measures

Name	Time	Method
Grades of Laryngeal View	Assessed intraoperatively at time of intubation	Cormack Lehane (1-4) and percentage of glottic opening (POGO) (%) will be recorded after insertion of the laryngoscope.
Time to Successful Intubation	Assessed intraoperatively at time of intubation	The time to intubation will be measured (seconds) to measure the time to intubation of the successful attempt.
Intraoperative Complications	Assessed intraoperatively for the duration of the surgery	Airway/device related complications including, laryngospasm, bronchospasm, regurgitation/aspiration, oxygen desaturation, will be measured.
Postoperative Complications	Outcome measure will be assessed postoperatively in the immediate phase 1 recovery unit for an average of 1 hour.	Airway/device related complications including sore throat, hoarseness, persistent coughing, stridor, and others will be measured during the post-operative period.
Ease of Endotracheal Tube Passage	Assessed intraoperatively at time of intubation	The ease of tracheal tube passage will be measured following tracheal intubation.