KingVision Video Laryngoscopy vs Direct Laryngoscopy - Equivalence Trial

NCT02590237 | Completed

• 1 other identifier: 2015-304
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tracheal Intubation

Keywords

Laryngoscopy; Video Laryngoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• First Attempt Success Rate of Tracheal Intubation

  Assessed intraoperatively at time of intubation

• Grades of Laryngeal View

  Assessed intraoperatively at time of intubation

• Intubation Adjustments & Ease of Use

  Assessed intraoperatively following intubation

• Hemodynamic Parameters - Heart Rate

  Assessed intraoperatively at time of and following intubation

• Hemodynamic Parameters - Blood Pressure

  Assessed intraoperatively at time of and following intubation

Study Arms (2)

Direct Laryngoscopy

ACTIVE COMPARATOR

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

Device: Miller Direct Laryngoscopy

KingVision Video Laryngoscope

EXPERIMENTAL

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

Device: Ambu KingVision Video Laryngoscope aBlade

Interventions

Ambu KingVision Video Laryngoscope aBlade DEVICE

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.

KingVision Video Laryngoscope

Miller Direct Laryngoscopy DEVICE

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.

Direct Laryngoscopy

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead

Study Sites (1)

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Related Publications (5)

• 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.

  PMID: 20674088 BACKGROUND

• 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.

  PMID: 23556410 BACKGROUND

• 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.

  PMID: 24742495 BACKGROUND

• 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.

  PMID: 23812581 BACKGROUND

• 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.

  PMID: 28549081 DERIVED

Study Officials

• Narasimhan Jagannathan, MD

  Ann & Robert Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: October 27, 2015
• First Posted: October 28, 2015
• Study Start: October 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 3, 2016

Record last verified: 2016-09

Locations

US (1)