King Vision Video Laryngoscope aBlade System for Use in Children
Phase: NA
Conditions: Pediatric Anesthesia, King Vision Video Laryngoscope Intubation
Sponsor: Indiana University

 
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Protocol  
 
Performance of the King Vision 
Video Laryngoscope for Tracheal 
Intubation of Pediatric Patients 
 
Principal Investigator 
Nicole Horn, M.D. 
Assistant Professor of Anesthesia 
705 Riley Hospital Drive, Room 2820 
Indianapolis, IN 46202 
Phone: 317-944-9835 
FAX: 317-944-0282 
Email: nhorn@iuhealth.org 
 
Sub Investigators 
 
Jodie Johnson, M.D. 
Assistant Professor of Clinical Anesthesia 
Michael Mazurek, M.D. 
Associate Professor of Clinical Anesthesia 
Eugene Presto, M.D. 
Assistant Professor of Clinical Anesthesia 
 
Version 2.0 
Dated: August 21, 2015 
 
 

 
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Table of Contents 
 
Study Schema 
1.0 Background 
2.0 Rationale and Specific Aims 
3.0 Inclusion/Exclusion Criteria 
4.0 Enrollment/Randomization 
5.0 Study Procedures 
6.0 Reporting of Adverse Events or Unanticipated Problems    
        Involving Risk to Participants or Others 
7.0 Statistical Considerations 
9.0 Privacy/Confidentiality Issues 
10.0 Follow-up and Record Retention 
 

 
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1.0 
Background 
Airway management is a critical component of anesthesia care.  Failure to 
provide adequate ventilation and oxygenation can lead to death or 
permanent neurologic disability.  Tracheal intubation provides a secure 
airway that is mandatory for many surgical procedures.  Intubation of the 
trachea requires some type of instrument that permits visualization of the 
glottic inlet during insertion of the tracheal tube through the larynx and into 
the trachea.  For many decades, the standard laryngoscope has consisted of a 
handle and a folding blade.   The blade may be straight or curved.  The 
purpose of the blade is to displace the tongue and sublingual tissue into the 
sub-mandibular space to provide the anesthesiologist with direct line-of-
sight to the laryngeal inlet.  Since the blade exerts pressure and displaces 
tissue, there is some risk of injury to the oral cavity and pharynx.  Difficulty 
with conventional laryngoscopy can be as high as 13 percent.1   Advances in 
imaging technology promoted the design of new laryngoscopes that provide 
an image of the larynx with indirect line-of-sight.  The essence of these 
devices is a CCD chip or “miniature camera” that is placed at the tip of the 
laryngoscope.  The image is transmitted to a screen for the anesthesiologist 
to observe.  These laryngoscopes have been termed video laryngoscopes.  
Video laryngoscopes reduce pressure on the soft tissue of the upper airway 
and provide a high-resolution, wide angle view of the upper airway and 
larynx.  Video laryngoscopes, consequently, decrease the risk of upper airway 
trauma and improve the ease of tracheal intubation.  The first video 

 
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laryngoscope introduced into clinical practice was the Glidescope (Verathon 
Medical, 2003).2   Since the introduction of video laryngoscopes most 
anesthesia departments and critical care departments, including ours, have 
had a steady increase in the use of video laryngoscopes in place of 
conventional laryngoscopes.3,4,5   Many anesthesiologists now use video 
laryngoscopes as their standard laryngoscope.  Video laryngoscopy is also 
included in current guidelines for difficult tracheal intubation.6   Other video 
laryngoscopes in clinical use throughout the world include the CMAC (Kart 
Storz Imaging), Tru-View (Truphatek), McGrath (Covidien), Pentax AWS 
(Pentax), and the King Vision (Ambu).  Some of these devices have pediatric 
sized blades and some do not. 
     Processing, portability, and cost are important aspects of video 
laryngoscope selection.  Some devices have patient contact components that 
are disposable, while other devices are reusable and require processing for 
sterilization or high-grade disinfection.  Patient cross-contamination with 
potentially infectious material is an increasing concern with reusable airway 
devices.7   Cost is always a concern.  Some video laryngoscopes require a 
separate stand and monitor, and reusable blades.   The initial capital outlay 
for such reusable devices can be as high as $35,000.  The initial financial 
outlay for the King Vision is $1500. 
     The King Vision video laryngoscope was introduced into clinical practice 
in 2011.  The King Vision video laryngoscope is an FDA Device Class CCW 
instrument that is 510(K) exempt: regulation number 868.5540.  This device 

 
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consists of a reusable, imaging wand that is inserted into a disposable blade 
(size 3).  Published reports have documented the value of the King Vision 
video laryngoscope in older children and adults. 8,9   The size 3 blade is 
suitable for intubation of adults and children as young as 8 years.   Ambu 
now makes size 1 and 2 blades suitable for intubation of infants and young 
children.  The purpose of this study is to evaluate the performance of the 
King Vision video laryngoscope in younger patients.  Advantages of the King 
Vision scope include a very high success rate of first pass intubation, 
relatively low cost ($11 per intubation) and extreme portability. 
 
2.0 
Rationale and Specific Aims 
The purpose of this study is to evaluate the performance characteristics 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. 
3.0 
Inclusion/Exclusion Criteria 
Inclusion:  
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.   
 

 
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Exclusion: 
1. Patients that will be excluded are those with an airway examination or 
previous anesthesia history that suggests difficulty with mask ventilation. 
4.0 
Enrollment/Randomization 
100 patients will be enrolled.  Data will be collected from the patients that 
the King Vision Video Laryngoscope is used.  As this is not a comparative 
study, there shall be no randomization. 
5.0 
Study Procedures 
All procedures shall be routine procedures for the administration of 
anesthesia appropriate for the age of the child and the type of surgical 
procedure. This is a data collection only study .  
1. The technique of anesthesia induction will be determined for each patient 
by the anesthesiologist of record. 
2. After the induction of anesthesia, and when the patient is at an adequate 
depth of anesthesia, tracheal intubation will be performed with the King 
Vision video laryngoscope by one of the investigators.  
3. Data recorded will include gender, age, and weight of the patient.   
4. Data specific to the device and tracheal intubation include; size and type 
of blade (standard vs. channeled), blade tip position, Cormack-Lehane 
score, tracheal tube size, and a subjective scoring of tracheal tube 
delivery. 
5. See the attached data collection sheet.  
 

 
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6.0 
Reporting of Adverse Events or Unanticipated Problems   
Involving Risk to Participants or Others 
We do not anticipate adverse events related to this study.  This is a data 
collections only study therefore there are minimal to no risks to the subjects.  
There is a minimal risk of loss of confidentiality. PHI will be accessed for 
recruitment purposes by the clinical care team and/or research care team.  
All data shared with the sponsor will be unidentifiable.  
Any reports of adverse events can be made to: 
Nicole Horn, M.D. @ Office number: 317-944-9835 or Pager: 317-312-2570 
7.0 
Statistical Considerations 
As this is not a comparative study, only descriptive statistics will be applied. 
8.0 
Privacy/Confidentiality Issue 
Data will be kept secure in a password protected database and all paper 
documentation will be kept in a secure office of the Anesthesia department.  
10.0 Follow-up and Record Retention 
There will not be a follow up period for this study.  Records will be kept until 
all data analysis is complete and the study has been completed.  
 
 
 
 

 
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References: 
1. Heidegger T, Gerig HJ, Ulrich B, Kreienbuhl G:  Validation of a simple 
algorithm for tracheal intubation: daily practice is the key to success in 
emergencies—an analysis of 13, 248 intubations.  Anesth Analg  
2001;92:517-22. 
2. Cooper RM: Use of a new videolaryngoscope (Glidescope) in the 
management of the difficult airway.  Can J Anaesth  2003;50:611-13. 
3. Wanderer JP, Ehrenfeld JM, Sandberg WS, Epstein RH: The changing 
scope of difficult airway management.  Can J Anaesth 2013;60:1022-24. 
4. Silverberg MJ, Kory P:  Survey of video laryngoscopy use by U.S. critical 
care fellowship training programs.  Ann Am Thorac Soc  2014;11:1225-
29. 
5. Aziz MF, Kim D, Mako J, Hand K, Brambrink AM:  A retrospective study of 
the performance of video laryngoscopy in an obstetric unit.  Anesth Analg 
2012;115:904-6. 
6. ASA Taskforce on Management of the Difficult Airway: Practice guidelines 
for management of the difficult airway. Anesthesiology 2013;118:251-70. 
7. Negri de Sousa AC, Levy CE, Freitas MIP:  Laryngoscope blades and 
handles as sources of cross-infection: an integrative review.  J Hosp Infect 
2013;83:269-75. 
8. Murphy LD, Kovacs GJ, Reardon PM, Law JA:  Comparison of the King 
Vision video laryngoscope with the Macintosh laryngoscope.  J Emerg 
Med  2014;47:239-46. 

 
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9. El-Tahhan MR, Doyle DJ, Khidr AM, AbdulShafi M, Regal MA, Othman MS: 
Use of the King Vision video laryngoscope to facilitate fibreoptic 
intubation in critical tracheal stenosis proves superior to the Glidescope.  
Can J Anaesth 2014;61:213-14.