King Vision Video Laryngoscope Ambu (aBlade) System for Use in Children

NCT ID: NCT02841189

Last Updated: 2020-06-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-11-07

Brief Summary

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This is a single center trial to evaluate the performance of the King Vision video laryngoscope in pediatric patients between the ages of one month and 10 years of age. If the performance is satisfactory, this device may become a standard laryngoscope for tracheal intubation in elective and emergent tracheal intubations.

Detailed Description

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Conditions

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Pediatric Anesthesia King Vision Video Laryngoscope Intubation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Video laryngoscope intubation

The King Vision Video Laryngoscope will be used for intubation

Group Type OTHER

King Vision video Laryngoscope

Intervention Type DEVICE

The King Vision video laryngoscope (Ambu) will be used for tracheal intubation.

Interventions

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King Vision video Laryngoscope

The King Vision video laryngoscope (Ambu) will be used for tracheal intubation.

Intervention Type DEVICE

Other Intervention Names

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Ambu

Eligibility Criteria

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Inclusion Criteria

1. All children between the ages of 1 month to 10 years with a normal preoperative airway examination
2. Scheduled for a surgical procedure that requires tracheal intubation shall be included.

Exclusion Criteria

1\. Patients that will be excluded are those with an airway examination or previous anesthesia history that suggests difficulty with mask ventilation.
Minimum Eligible Age

1 Month

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Systems Corporation

INDUSTRY

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Nicole Horn

pediatric anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicole Horn, MD

Role: PRINCIPAL_INVESTIGATOR

Riley Hospital

Locations

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Riley Hospital for Children at IU Health

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Document Type: Statistical Analysis Plan: Data collection Sheet

View Document

Other Identifiers

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1409265337

Identifier Type: -

Identifier Source: org_study_id

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