A Comparison of Video Laryngoscopes and the Direct Laryngoscope in Simulated Normal and Difficult Infant Airway. (Kivi)

A Comparison of the Novel King Vision Pediatric aBlade and the C-MAC Video Laryngoscope to the Direct Laryngoscope in Simulated Normal and Difficult Infant Airway. A Bicentric, Prospective, Randomized Manikin Study

In Pediatric both manikin and human studies have suggested that the video laryngoscopy is equally suitable to facilitate intubation compared to the direct laryngoscopy.

Study Overview

• Status: Completed
• Conditions: Airway Complication of Anesthesia
• Intervention / Treatment: Device: normal airway; Device: difficult airway

Detailed Description

The King Vision Pediatric aBlade is a novel video laryngoscopy for securing the airway of new born and infants. In this manikin studie we want to compare different types of video laryngoscopes in a simulated normal and difficult infant airway.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Rhineland-Palatinate
    • Mainz, Rhineland-Palatinate, Germany, 55131
      • Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- anesthesiologists or neonatal/pediatric intensive care medicice specialists with experience in securing pediatric airway

Exclusion Criteria:

- participants without experience in pediatric airway management

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: normal airway; Time (normal airway) using the novel King Vision™ Pediatric aBlade (KV) video laryngoscope, C-MAC™ D-blade Ped (DP), C-MAC™ Miller Blade (MB), shortened as VL, compared with conventional direct laryngoscopy (DL)	Device: normal airway; The Time interval between the laryngoscope blade passing the teeth/gums to the announcing of the first ventilation was recorded as the time to ventilation with the Video laryngoscopy (VL) or conventional direct laryngoscopy (DL); Device: difficult airway; The Time interval between the laryngoscope blade passing the teeth/gums to the announcing of the first ventilation was recorded as the time to ventilation with the Video laryngoscopy (VL) or conventional direct laryngoscopy (DL)
Experimental: difficult airway; Time (difficult airway) using the novel King Vision™ Pediatric aBlade (KV) video laryngoscope, C-MAC™ D-blade Ped (DP), C-MAC™ Miller Blade (MB), shortened as VL, compared with conventional direct laryngoscopy (DL)	Device: normal airway; The Time interval between the laryngoscope blade passing the teeth/gums to the announcing of the first ventilation was recorded as the time to ventilation with the Video laryngoscopy (VL) or conventional direct laryngoscopy (DL); Device: difficult airway; The Time interval between the laryngoscope blade passing the teeth/gums to the announcing of the first ventilation was recorded as the time to ventilation with the Video laryngoscopy (VL) or conventional direct laryngoscopy (DL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to ventilation (seconds)	Three timepoints will be recorded, beginning with the insertion of the device past the theeth/gum into the mouth. These will inlcude time to best view, time to removal of device from the mouth, and the time to the first chest raising of the simulator	Assessed intraoperatively at time of intubation (seconds)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First attempt success rate of tracheal intubation (in 40 seconds)	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 Class)	Cormack&Lehane Grade (1-4) and percentage of glottic opening (POGO) (%) will be recorded after insertion of the laryngoscope	Assessed intraoperatively at time of intubation
Use of ELM	BURP or change the head/Shoulder position to optimised the glottic view will be recorded	Assessed intraoperatively at time of intubation
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

Collaborators and Investigators

• Sponsor: Johannes Gutenberg University Mainz
• Investigators: Principal Investigator: Marc Kriege, MD, University Medical Centre Mainz

Publications and helpful links

General Publications

• 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 (Actual): July 24, 2017
• Primary Completion (Actual): July 31, 2017
• Study Completion (Actual): September 27, 2017

Study Registration Dates

• First Submitted: July 23, 2017
• First Submitted That Met QC Criteria: July 25, 2017
• First Posted (Actual): July 26, 2017

Study Record Updates

• Last Update Posted (Actual): October 2, 2017
• Last Update Submitted That Met QC Criteria: September 28, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: infant, laryngoscopes, pediatrics
• Other Study ID Numbers: Johannes GU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No