KingVision Video Laryngoscopy vs Direct Laryngoscopy - Equivalence Trial

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

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.

Study Overview

• Status: Completed
• Conditions: Tracheal Intubation
• Intervention / Treatment: Device: Miller Direct Laryngoscopy; Device: Ambu KingVision Video Laryngoscope aBlade

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ann & Robert H Lurie Children's Hospital of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

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
Active Comparator: Direct Laryngoscopy; The trachea will be intubated via direct laryngoscopy using a traditional straight blade (Miller) laryngoscope.	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.
Experimental: KingVision Video Laryngoscope; The trachea will be intubated using the Ambu KingVision Video Laryngoscope size 1 pediatric blade.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Intubation	Three timepoints will be recorded, beginning with insertion of the device past the lips into the mouth. These will include time to optimal glottic view, time to removal of device from mouth, and time to first CO2 capnography upstroke. The primary outcome measure will be total time to intubation, as the sum of all three timepoints.	Assessed intraoperatively at time of intubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intubation Adjustments & Ease of Use	Airway manipulations utilized and ease of use (Likert 1-5) will be assessed by the user following the intubation.	Assessed intraoperatively following intubation
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
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
Hemodynamic Parameters - Heart Rate	Heart rate (beats per minute) will be assessed prior to intubation and at 1 minute intervals, for 5 minutes, following intubation.	Assessed intraoperatively at time of and following intubation
Hemodynamic Parameters - Blood Pressure	Blood pressure (mmHg) will be assessed prior to intubation and at 1 minute intervals, for 5 minutes, following intubation.	Assessed intraoperatively at time of and following intubation
Intraoperative Complications	Airway/device related complications including, laryngospasm, bronchospasm, oxygen desaturation, will be assessed at intubation, during the surgery, and after extubation while under the anesthesiologists care.	Assessed intraoperatively
Postoperative Complications	Airway/device related complications including sore throat, hoarseness, persistent coughing, stridor, and others will be assessed in the post anesthesia care unit.	Assessed postoperatively while admitted to the phase 1 recovery unit, approximately 30-60 minutes after surgery

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.
• Jagannathan N, Hajduk J, Sohn L, Huang A, Sawardekar A, Albers B, Bienia S, De Oliveira GS. Randomized equivalence trial of the King Vision aBlade videolaryngoscope with the Miller direct laryngoscope for routine tracheal intubation in children <2 yr of age. Br J Anaesth. 2017 Jun 1;118(6):932-937. doi: 10.1093/bja/aex073.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: October 27, 2015
• First Submitted That Met QC Criteria: October 27, 2015
• First Posted (Estimate): October 28, 2015

Study Record Updates

• Last Update Posted (Estimate): October 3, 2016
• Last Update Submitted That Met QC Criteria: September 29, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

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