Comparison of Videolaryngoscopy and Direct Laryngoscopy in Pediatric Airway Management

NCT ID: NCT03571295

Last Updated: 2021-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2020-09-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Airway Management Videolaryngoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Caregivers

Study Groups

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videolaryngoscopy

Group Type EXPERIMENTAL

King Vision aBlade

Intervention Type DEVICE

endotracheal intubation performed with King Vision aBlade

direct laryngoscopy

Group Type EXPERIMENTAL

direct laryngoscopy

Intervention Type DEVICE

endotracheal intubation performed with direct laryngoscopy

Interventions

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King Vision aBlade

endotracheal intubation performed with King Vision aBlade

Intervention Type DEVICE

direct laryngoscopy

endotracheal intubation performed with direct laryngoscopy

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johannes Gutenberg University Mainz

OTHER

Sponsor Role lead

Responsible Party

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Nina Pirlich, Dr. med.

Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Johannes Gutenberg - Universität

Mainz, Rhineland-Palatinate, Germany

Site Status

Countries

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Germany

Other Identifiers

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Learn a Blade 1.0

Identifier Type: -

Identifier Source: org_study_id

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