Comparison of Videolaryngoscopy and Direct Laryngoscopy in Pediatric Airway Management (LearnaBlade)

A Comparison of Direct Laryngoscopy and King Vision® aBlade™ Videolaryngoscopy in Paediatric Airway Management: Success Rate and Learning Curve of Trainee Anaesthetists

The investigators intended to evaluate first success rate and learning curve of trainee anesthetists performing direct and videolaryngoscopy in pediatric airway management.

Study Overview

• Status: Completed
• Conditions: Airway Management; Videolaryngoscopy
• Intervention / Treatment: Device: King Vision aBlade; Device: direct laryngoscopy

Detailed Description

After obtaining written informed consent of 10 trainee anesthetists with non less than 24 months and not exceeding 60 months residency, use of the King Vision aBlade videolaryngoscope was demonstrated by presenting a 2 min instruction video. First endotracheal intubation by each trainee anesthetist was randomly allocated to either direct (DL) or King Vision aBlade videolaryngoscopy (KingVL). Then order of laryngoscopy type was alternating at least each trainee anesthetists performed 10 DL and 10 KingVL endotracheal intubations.

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Rhineland Palatinate
    • Mainz, Rhineland Palatinate, Germany, 55131
      • Johannes Gutenberg - Universität

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA 1 to 2
• written informed consent from both legal guardians
• children who were scheduled for nonemergency surgery with requirement of endotracheal intubation

Exclusion Criteria:

• known or predicted difficult airway
• increased risk for pulmonary aspiration

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: videolaryngoscopy	Device: King Vision aBlade; endotracheal intubation performed with King Vision aBlade
Experimental: direct laryngoscopy	Device: direct laryngoscopy; endotracheal intubation performed with direct laryngoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
first attempt success rate of endotracheal intubation	yes/no	operation day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total time for successful intubation	in sec	operation day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
failure category of the first attempt	First attempt failed when esophageal intubation or oxygen desaturation < 90% occurred.	operation day

Collaborators and Investigators

• Sponsor: Johannes Gutenberg University Mainz

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: May 22, 2018
• First Submitted That Met QC Criteria: June 26, 2018
• First Posted (Actual): June 27, 2018

Study Record Updates

• Last Update Posted (Actual): August 30, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: learning curve; pediatric airway management
• Other Study ID Numbers: Learn a Blade 1.0

Drug and device information, study documents

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