Efficiency of the King Vision Video Laryngoscope
Primary Purpose
Respiratory Failure, Intubation
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Macintosh laryngoscope
King Vision video laryngoscope
Sponsored by
About this trial
This is an interventional other trial for Respiratory Failure
Eligibility Criteria
Inclusion Criteria:
- scheduled for general anesthesia
- age higher than 18 years
- age lower than 60 years
Exclusion Criteria:
- emergency surgery
- mouth opening less than 2 cm
- American Society of Anesthesiologists (ASA) score higher than 2
- oropharyngeal anomaly
- glottic or supraglottic mass
- history of surgery due to oropharyngeal anomaly, glottic or supraglottic mass
Sites / Locations
- Recep Tayyip Erdogan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Macintosh
KingVision
Arm Description
Patients scheduled for general anesthesia during the period from January 2014 to June 2014. Each patient has been intubated with a Macintosh laryngoscope.
Patients scheduled for general anesthesia during the period from January 2014 to June 2014. Each patient has been intubated with a King Vision video laryngoscope.
Outcomes
Primary Outcome Measures
Intubation Success Rate
Endotracheal intubation attempt is defined as entrance of the endotracheal tube into the patient's mouth. Any major change in the alignment of the laryngoscope is defined as another intubation attempt. Successful endotracheal intubation is defined as the endotracheal cuff passing through the patient's vocal cords. Intubation success rate is defined as: 1 / [the number of attempts].
Secondary Outcome Measures
Intubation Time
Successful endotracheal intubation is defined as the endotracheal cuff passing the patient's vocal cords. Time to intubation with each laryngoscope is recorded.
Glottic View Time
Glottic view time (as defined when the laryngoscopist declared the best Cormack-Lehane score) with each laryngoscope is recorded.
Cormack-Lehane score is obtained by directly assessing the distance between the base of the tongue and the roof of the mouth to predict how diffcult an intubation will be.
It consists of 4 grades:
full view of glottis (difficult intubation unlikely)
partial view of glottis (~5% risk of difficult intubation)
partial view of epiglottis, none of glottis seen (~90% risk of difficult intubation)
neither glottis nor epiglottis seen (difficult intubation very likely)
Cormack-Lehane Score
Best Cormack-Lehane score (as declared by the laryngoscopist) obtained with both laryngoscopes is recorded.
Cormack-Lehane score is graded according to the following criteria (1 is best, and 4 is worst):
full view of glottis (difficult intubation unlikely)
partial view of glottis (~5% risk of difficult intubation)
partial view of epiglottis, none of glottis seen (~90% risk of difficult intubation)
neither glottis nor epiglottis seen (difficult intubation very likely)
Airway Complications
Any complication related to the laryngoscopy and intubation, such as cut, bleeding, damage to the teeth, laryngospasm, bronchospasm, desaturation below 90%, is recorded.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02482870
Brief Title
Efficiency of the King Vision Video Laryngoscope
Official Title
Comparison of King Vision Video Laryngoscope and Macintosh Laryngoscope in Terms of First Pass Intubation Success Rate, Intubation Time, Glottic View Time, and Complications Related to Laryngoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rize Üniversitesi
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators studied the efficiency of Macintosh laryngoscope and the King Vision video laryngoscope in adult patients scheduled for general anesthesia. Best Cormack-Lehane score obtained, glottic view time, intubation time, time to ventilation, correlation between the Mallampati classification and the Cormack-Lehane grades, and complications related to laryngoscopy and intubation has been investigated.
Detailed Description
Securing the airway is essential in general anesthesia. Anesthetic problems related to airway management constitute 17% of closed claims, difficult intubation being the most common one with an occurrence rate of 5%. Problems like delayed intubation, misplaced tracheal tube, or airway trauma are frequently seen in outpatient settings and end up with either death or hypoxic brain damage. Therefore, preoperative visit should include detailed assessment of the airways according to clues of difficult intubation.Several studies compared the King Vision video laryngoscope with other laryngoscopes in manikins simulating difficult airway scenarios, and reported better glottic views. The investigators aimed to study the correlation between the Mallampati classification and the glottic views (Cormack-Lehane grade) obtained with Macintosh laryngoscopy, and the King Vision video laryngoscopy in adult patients scheduled for general anesthesia. Secondary outcomes will be successful intubation rate, time to obtain the best view, time to successful intubation, and complications related to laryngoscopy will be compared.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure, Intubation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
388 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Macintosh
Arm Type
Active Comparator
Arm Description
Patients scheduled for general anesthesia during the period from January 2014 to June 2014. Each patient has been intubated with a Macintosh laryngoscope.
Arm Title
KingVision
Arm Type
Active Comparator
Arm Description
Patients scheduled for general anesthesia during the period from January 2014 to June 2014. Each patient has been intubated with a King Vision video laryngoscope.
Intervention Type
Device
Intervention Name(s)
Macintosh laryngoscope
Intervention Description
Using a Macintosh laryngoscope, time to glottic view, best Cormack-Lehane grade, time to intubation, time to first ventilation has been recorded.
Intervention Type
Device
Intervention Name(s)
King Vision video laryngoscope
Intervention Description
Using a King Vision video laryngoscope, time to glottic view, best Cormack-Lehane grade, time to intubation, time to first ventilation has been recorded.
Primary Outcome Measure Information:
Title
Intubation Success Rate
Description
Endotracheal intubation attempt is defined as entrance of the endotracheal tube into the patient's mouth. Any major change in the alignment of the laryngoscope is defined as another intubation attempt. Successful endotracheal intubation is defined as the endotracheal cuff passing through the patient's vocal cords. Intubation success rate is defined as: 1 / [the number of attempts].
Time Frame
less than 24 hours
Secondary Outcome Measure Information:
Title
Intubation Time
Description
Successful endotracheal intubation is defined as the endotracheal cuff passing the patient's vocal cords. Time to intubation with each laryngoscope is recorded.
Time Frame
less than 24 hours
Title
Glottic View Time
Description
Glottic view time (as defined when the laryngoscopist declared the best Cormack-Lehane score) with each laryngoscope is recorded.
Cormack-Lehane score is obtained by directly assessing the distance between the base of the tongue and the roof of the mouth to predict how diffcult an intubation will be.
It consists of 4 grades:
full view of glottis (difficult intubation unlikely)
partial view of glottis (~5% risk of difficult intubation)
partial view of epiglottis, none of glottis seen (~90% risk of difficult intubation)
neither glottis nor epiglottis seen (difficult intubation very likely)
Time Frame
less than 24 hours
Title
Cormack-Lehane Score
Description
Best Cormack-Lehane score (as declared by the laryngoscopist) obtained with both laryngoscopes is recorded.
Cormack-Lehane score is graded according to the following criteria (1 is best, and 4 is worst):
full view of glottis (difficult intubation unlikely)
partial view of glottis (~5% risk of difficult intubation)
partial view of epiglottis, none of glottis seen (~90% risk of difficult intubation)
neither glottis nor epiglottis seen (difficult intubation very likely)
Time Frame
less than 24 hours
Title
Airway Complications
Description
Any complication related to the laryngoscopy and intubation, such as cut, bleeding, damage to the teeth, laryngospasm, bronchospasm, desaturation below 90%, is recorded.
Time Frame
The participants' will be followed for the duration of hospital stay, an expected average of 2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
scheduled for general anesthesia
age higher than 18 years
age lower than 60 years
Exclusion Criteria:
emergency surgery
mouth opening less than 2 cm
American Society of Anesthesiologists (ASA) score higher than 2
oropharyngeal anomaly
glottic or supraglottic mass
history of surgery due to oropharyngeal anomaly, glottic or supraglottic mass
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Başar Erdivanli, Asst. Prof.
Organizational Affiliation
Recep Tayyip Erdogan Univeristy, Medical Faculty, Department of Anesthesiology and Reanimation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Recep Tayyip Erdogan University
City
Rize
ZIP/Postal Code
53100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
21550550
Citation
Metzner J, Posner KL, Lam MS, Domino KB. Closed claims' analysis. Best Pract Res Clin Anaesthesiol. 2011 Jun;25(2):263-76. doi: 10.1016/j.bpa.2011.02.007.
Results Reference
background
Citation
Woodall NM, Benger JR, Harper JS, Cook TM. Airway management complications during anaesthesia, in intensive care units and in emergency departments in the UK". Trends in Anaesthesia and Critical Care 2(2): 58-64, 2012.
Results Reference
background
PubMed Identifier
11871945
Citation
Yentis SM. Predicting difficult intubation--worthwhile exercise or pointless ritual? Anaesthesia. 2002 Feb;57(2):105-9. doi: 10.1046/j.0003-2409.2001.02515.x. No abstract available.
Results Reference
background
PubMed Identifier
23812581
Citation
Akihisa 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.
Results Reference
background
PubMed Identifier
24742495
Citation
Murphy 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.
Results Reference
background
PubMed Identifier
24460509
Citation
Yun BJ, Brown CA 3rd, Grazioso CJ, Pozner CN, Raja AS. Comparison of video, optical, and direct laryngoscopy by experienced tactical paramedics. Prehosp Emerg Care. 2014 Jul-Sep;18(3):442-5. doi: 10.3109/10903127.2013.864356. Epub 2014 Jan 24.
Results Reference
background
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Efficiency of the King Vision Video Laryngoscope
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