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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02841189
Recruitment Status : Completed
First Posted : July 22, 2016
Results First Posted : June 2, 2020
Last Update Posted : June 2, 2020
Sponsor:
Collaborator:
King Systems Corporation
Information provided by (Responsible Party):
Nicole Horn, Indiana University

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.

Condition or disease Intervention/treatment Phase
Pediatric Anesthesia King Vision Video Laryngoscope Intubation Device: King Vision video Laryngoscope Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: King Vision Video Laryngoscope aBlade System for Use in Children
Study Start Date : December 2014
Actual Primary Completion Date : November 7, 2017
Actual Study Completion Date : November 7, 2017

Arm Intervention/treatment
Video laryngoscope intubation
The King Vision Video Laryngoscope will be used for intubation
Device: King Vision video Laryngoscope
The King Vision video laryngoscope (Ambu) will be used for tracheal intubation.
Other Name: Ambu




Primary Outcome Measures :
  1. Ease of Endotracheal Intubation [ Time Frame: During intubation ]
    Ease of endotracheal intubation



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02841189


Locations
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United States, Indiana
Riley Hospital for Children at IU Health
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
King Systems Corporation
Investigators
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Principal Investigator: Nicole Horn, MD Riley Hospital
  Study Documents (Full-Text)

Documents provided by Nicole Horn, Indiana University:
Informed Consent Form  [PDF] May 18, 2016

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Responsible Party: Nicole Horn, pediatric anesthesiologist, Indiana University
ClinicalTrials.gov Identifier: NCT02841189    
Other Study ID Numbers: 1409265337
First Posted: July 22, 2016    Key Record Dates
Results First Posted: June 2, 2020
Last Update Posted: June 2, 2020
Last Verified: May 2020