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NCT03571295 Clinical Trial

Comparison of Videolaryngoscopy and Direct Laryngoscopy in Pediatric Airway Management

Airway Management Clinical Trial

— LearnaBlade  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03571295
Other study ID # Learn a Blade 1.0
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2018
Est. completion date September 1, 2020

Study information
Verified date August 2021
Source Johannes Gutenberg University Mainz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 210
Est. completion date September 1, 2020
Est. primary completion date July 1, 2020
Accepts healthy volunteers No
Gender All
Age group 1 Year to 10 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• King Vision aBlade
endotracheal intubation performed with King Vision aBlade
• direct laryngoscopy
endotracheal intubation performed with direct laryngoscopy

Locations
Country Name City State
Germany Johannes Gutenberg - Universität Mainz Rhineland Palatinate

Sponsors (1)
Lead Sponsor Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Other failure category of the first attempt First attempt failed when esophageal intubation or oxygen desaturation < 90% occurred. operation day
Primary first attempt success rate of endotracheal intubation yes/no operation day
Secondary total time for successful intubation in sec operation day
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