Clinical trial NCT02384564: King Vision Video Laryngoscope aBlade vs. Direct Laryngoscopy in Children
Official title: A Randomized Comparison of the King Vision Video Laryngoscope aBlade vs. Direct Laryngoscopy in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tracheal Intubation
Keywords: Laryngoscopy
Video Laryngoscopy
Tracheal intubation
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2015-03-10
Enrollment: 140
Sex: ALL
Minimum age (years): 1
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: First Attempt Success Rate of Tracheal Intubation
timeFrame: Assessed intraoperatively at time of intubation
Secondary outcomes:
measure: Grades of Laryngeal View
timeFrame: Assessed intraoperatively at time of intubation
measure: Time to Successful Intubation
timeFrame: Assessed intraoperatively at time of intubation
measure: Intraoperative Complications
timeFrame: Assessed intraoperatively for the duration of the surgery
measure: Postoperative Complications
timeFrame: Outcome measure will be assessed postoperatively in the immediate phase 1 recovery unit for an average of 1 hour.
measure: Ease of Endotracheal Tube Passage
timeFrame: Assessed intraoperatively at time of intubation
Other outcomes:
Locations:
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.