NCT02841189

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 13, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 22, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2017

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

June 2, 2020

Completed
Last Updated

June 2, 2020

Status Verified

May 1, 2020

Enrollment Period

2.9 years

First QC Date

May 13, 2016

Results QC Date

April 16, 2019

Last Update Submit

May 27, 2020

Conditions

Pediatric AnesthesiaKing Vision Video Laryngoscope Intubation

Outcome Measures

Primary Outcomes (1)

  • Ease of Endotracheal Intubation

    Ease of endotracheal intubation

    During intubation

Study Arms (1)

Video laryngoscope intubation

OTHER

The King Vision Video Laryngoscope will be used for intubation

Device: King Vision video Laryngoscope

Interventions

King Vision video LaryngoscopeDEVICE

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

Also known as: Ambu
Video laryngoscope intubation

Eligibility Criteria

Age1 Month - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riley Hospital for Children at IU Health

Indianapolis, Indiana, 46202, United States

Location

Results Point of Contact

Title
Nicole Horn MD
Organization
Indiana University
nhorn@iupui.edu
317-944-9981

Study Officials

  • Nicole Horn, MD

    Riley Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
pediatric anesthesiologist

Study Record Dates

First Submitted

May 13, 2016

First Posted

July 22, 2016

Study Start

December 1, 2014

Primary Completion

November 7, 2017

Study Completion

November 7, 2017

Last Updated

June 2, 2020

Results First Posted

June 2, 2020

Record last verified: 2020-05

Locations

US(1)