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NCT02841189 Clinical Trial

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

Pediatric Anesthesia Clinical Trial

Official title:
King Vision Video Laryngoscope aBlade System for Use in Children

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02841189
Other study ID # 1409265337
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2014
Est. completion date November 7, 2017

Study information
Verified date May 2020
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date November 7, 2017
Est. primary completion date November 7, 2017
Accepts healthy volunteers No
Gender All
Age group 1 Month to 10 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• King Vision video Laryngoscope
The King Vision video laryngoscope (Ambu) will be used for tracheal intubation.

Locations
Country Name City State
United States Riley Hospital for Children at IU Health Indianapolis Indiana

Sponsors (2)
Lead Sponsor Collaborator
Indiana University King Systems Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ease of Endotracheal Intubation Ease of endotracheal intubation During intubation
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