King Vision Video Laryngoscope aBlade vs. Direct Laryngoscopy in Children
A Randomized Comparison of the King Vision Video Laryngoscope aBlade vs. Direct Laryngoscopy in Children
1 other identifier
interventional
140
0 countries
N/A
Brief Summary
The purpose of this study is to determine whether there is a clinically relevant difference in first attempt success rates between the Ambu King Vision Video Laryngoscope and Direct Laryngoscopy in Children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2015
Shorter than P25 for not_applicable
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
First Submitted
Initial submission to the registry
February 26, 2015
CompletedFirst Posted
Study publicly available on registry
March 10, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedJuly 29, 2015
July 1, 2015
2 months
February 26, 2015
July 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
First Attempt Success Rate of Tracheal Intubation
An attempt at tracheal intubation will be defined as entry of the device into the patient's mouth without the need to remove the device once entered and securing the airway.
Assessed intraoperatively at time of intubation
Secondary Outcomes (5)
Grades of Laryngeal View
Assessed intraoperatively at time of intubation
Time to Successful Intubation
Assessed intraoperatively at time of intubation
Intraoperative Complications
Assessed intraoperatively for the duration of the surgery
Postoperative Complications
Outcome measure will be assessed postoperatively in the immediate phase 1 recovery unit for an average of 1 hour.
Ease of Endotracheal Tube Passage
Assessed intraoperatively at time of intubation
Study Arms (2)
Ambu King Vision Video Laryngoscope aBlade System
EXPERIMENTALThe trachea will be intubated using the Ambu King Vision Video Laryngoscope with the appropriate sized blade (size 1 or 2) based on manufacturer guidelines and clinical judgement.
Direct Laryngoscope
ACTIVE COMPARATORThe trachea will be intubated via direct laryngoscopy using a traditional straight blade laryngoscope, with appropriately sized blade based on manufacturer guidelines and clinical judgement.
Interventions
At time of tracheal intubation, the subject will be intubated using the Ambu King Vision Video Laryngoscope with the appropriately sized Ambu aBlade System based on manufacturer guidelines and clinical judgement. The first attempt to successful intubation will be assessed. The Cormack Lehane and Percentage of Glottic Opening scores will be recorded via direct vision. Information on subsequent attempts, time to successful intubation, and ease of tracheal tube insertion will be assessed.
At time of tracheal intubation, the subject will be intubated via direct laryngoscopy using a straight laryngoscope blade, based on manufacturer guidelines and clinical judgement. The first attempt to successful intubation will be assessed. The Cormack Lehane and Percentage of Glottic Opening scores will be recorded via direct vision. Information on subsequent attempts, time to successful intubation, and ease of tracheal tube insertion will be assessed.
Eligibility Criteria
You may qualify if:
- ASA (American Society of Anesthesiologists) I-III classified patients
- Patients undergoing procedure where an endotracheal tube would be normally utilized
You may not qualify if:
- Children with expected difficult airways
- Coagulopathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (4)
Levitan RM, Heitz JW, Sweeney M, Cooper RM. The complexities of tracheal intubation with direct laryngoscopy and alternative intubation devices. Ann Emerg Med. 2011 Mar;57(3):240-7. doi: 10.1016/j.annemergmed.2010.05.035. Epub 2010 Jul 31.
PMID: 20674088BACKGROUNDTheiler L, Hermann K, Schoettker P, Savoldelli G, Urwyler N, Kleine-Brueggeney M, Arheart KL, Greif R. SWIVIT--Swiss video-intubation trial evaluating video-laryngoscopes in a simulated difficult airway scenario: study protocol for a multicenter prospective randomized controlled trial in Switzerland. Trials. 2013 Apr 4;14:94. doi: 10.1186/1745-6215-14-94.
PMID: 23556410BACKGROUNDMurphy LD, Kovacs GJ, Reardon PM, Law JA. Comparison of the king vision video laryngoscope with the macintosh laryngoscope. J Emerg Med. 2014 Aug;47(2):239-46. doi: 10.1016/j.jemermed.2014.02.008. Epub 2014 Apr 16.
PMID: 24742495BACKGROUNDAkihisa Y, Maruyama K, Koyama Y, Yamada R, Ogura A, Andoh T. Comparison of intubation performance between the King Vision and Macintosh laryngoscopes in novice personnel: a randomized, crossover manikin study. J Anesth. 2014 Feb;28(1):51-7. doi: 10.1007/s00540-013-1666-9. Epub 2013 Jun 30.
PMID: 23812581BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
narasimhan jagannathan, MD
Ann & Robert Lurie Children's Hospital of Chicago
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Primary Investigator; M.D.
Study Record Dates
First Submitted
February 26, 2015
First Posted
March 10, 2015
Study Start
August 1, 2015
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
July 29, 2015
Record last verified: 2015-07