- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02841189
King Vision Video Laryngoscope Ambu (aBlade) System for Use in Children
May 27, 2020 updated by: Nicole Horn, Indiana University
King Vision Video Laryngoscope aBlade System for Use in Children
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Riley Hospital for Children at IU Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 10 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Video laryngoscope intubation
The King Vision Video Laryngoscope will be used for intubation
|
The King Vision video laryngoscope (Ambu) will be used for tracheal intubation.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ease of Endotracheal Intubation
Time Frame: During intubation
|
Ease of endotracheal intubation
|
During intubation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Nicole Horn, MD, Riley Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2014
Primary Completion (Actual)
November 7, 2017
Study Completion (Actual)
November 7, 2017
Study Registration Dates
First Submitted
May 13, 2016
First Submitted That Met QC Criteria
July 21, 2016
First Posted (Estimate)
July 22, 2016
Study Record Updates
Last Update Posted (Actual)
June 2, 2020
Last Update Submitted That Met QC Criteria
May 27, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 1409265337
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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