Clinical trial NCT02590237: KingVision Video Laryngoscopy vs Direct Laryngoscopy - Equivalence Trial
Official title: A Clinical Evaluation of the King Vision Video Laryngoscope aBlade System in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tracheal Intubation
Keywords: Laryngoscopy
Video Laryngoscopy
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2015-10-28
Enrollment: 200
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to Intubation
timeFrame: Assessed intraoperatively at time of intubation
Secondary outcomes:
measure: First Attempt Success Rate of Tracheal Intubation
timeFrame: Assessed intraoperatively at time of intubation
measure: Grades of Laryngeal View
timeFrame: Assessed intraoperatively at time of intubation
measure: Intubation Adjustments & Ease of Use
timeFrame: Assessed intraoperatively following intubation
measure: Hemodynamic Parameters - Heart Rate
timeFrame: Assessed intraoperatively at time of and following intubation
measure: Hemodynamic Parameters - Blood Pressure
timeFrame: Assessed intraoperatively at time of and following intubation
measure: Intraoperative Complications
timeFrame: Assessed intraoperatively
measure: Postoperative Complications
timeFrame: Assessed postoperatively while admitted to the phase 1 recovery unit, approximately 30-60 minutes after surgery
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H Lurie Children's Hospital of Chicago
state: Illinois
Study officials:
affiliation: Ann & Robert Lurie Children's Hospital of Chicago
name: Narasimhan Jagannathan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.