King Vision Video Laryngoscope aBlade vs. Direct Laryngoscopy in Children

A Randomized Comparison of the King Vision Video Laryngoscope aBlade vs. Direct Laryngoscopy in Children

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.

Study Overview

• Status: Unknown
• Conditions: Tracheal Intubation
• Intervention / Treatment: Device: Ambu King Vision Video Laryngoscope aBlade; Device: Direct Laryngoscopy via Miller Straight Blade

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 Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Narasimhan Jagannathan, MD; Phone Number: 312275170; Email: njagannathan@luriechildrens.org
• Study Contact Backup: Name: John Hajduk; Phone Number: 3122275295; Email: jhajduk@luriechildrens.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ambu King Vision Video Laryngoscope aBlade System; 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.	Device: Ambu King Vision Video Laryngoscope aBlade; At time of tracheal intubation, the subject will be intubated using the Ambu King Vision Video Laryngoscope with the appropriately sized Ambu aBlade System based on manufacturer guidelines and clinical judgement. The first attempt to successful intubation will be assessed. The Cormack Lehane and Percentage of Glottic Opening scores will be recorded via direct vision. Information on subsequent attempts, time to successful intubation, and ease of tracheal tube insertion will be assessed.; Other Names: King Vision Video Laryngoscope
Active Comparator: Direct Laryngoscope; 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.	Device: Direct Laryngoscopy via Miller Straight Blade; At time of tracheal intubation, the subject will be intubated via direct laryngoscopy using a straight laryngoscope blade, based on manufacturer guidelines and clinical judgement. The first attempt to successful intubation will be assessed. The Cormack Lehane and Percentage of Glottic Opening scores will be recorded via direct vision. Information on subsequent attempts, time to successful intubation, and ease of tracheal tube insertion will be assessed.; Other Names: Miller Blade, Wisconsin blade, Straight blade

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First Attempt Success Rate of Tracheal 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.	Assessed intraoperatively at time of intubation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
• Investigators: Principal Investigator: Narasimhan Jagannathan, MD, Ann & Robert Lurie Children's Hospital of Chicago

Publications and helpful links

General Publications

• Levitan RM, Heitz JW, Sweeney M, Cooper RM. The complexities of tracheal intubation with direct laryngoscopy and alternative intubation devices. Ann Emerg Med. 2011 Mar;57(3):240-7. doi: 10.1016/j.annemergmed.2010.05.035. Epub 2010 Jul 31.
• Akihisa Y, Maruyama K, Koyama Y, Yamada R, Ogura A, Andoh T. Comparison of intubation performance between the King Vision and Macintosh laryngoscopes in novice personnel: a randomized, crossover manikin study. J Anesth. 2014 Feb;28(1):51-7. doi: 10.1007/s00540-013-1666-9. Epub 2013 Jun 30.
• Murphy LD, Kovacs GJ, Reardon PM, Law JA. Comparison of the king vision video laryngoscope with the macintosh laryngoscope. J Emerg Med. 2014 Aug;47(2):239-46. doi: 10.1016/j.jemermed.2014.02.008. Epub 2014 Apr 16.
• Theiler L, Hermann K, Schoettker P, Savoldelli G, Urwyler N, Kleine-Brueggeney M, Arheart KL, Greif R. SWIVIT--Swiss video-intubation trial evaluating video-laryngoscopes in a simulated difficult airway scenario: study protocol for a multicenter prospective randomized controlled trial in Switzerland. Trials. 2013 Apr 4;14:94. doi: 10.1186/1745-6215-14-94.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): October 1, 2015
• Study Completion (Anticipated): October 1, 2015

Study Registration Dates

• First Submitted: February 26, 2015
• First Submitted That Met QC Criteria: March 4, 2015
• First Posted (Estimate): March 10, 2015

Study Record Updates

• Last Update Posted (Estimate): July 29, 2015
• Last Update Submitted That Met QC Criteria: July 27, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Laryngoscopy; Video Laryngoscopy; Tracheal intubation
• Other Study ID Numbers: IRB 2015-304