Efficiency of the King Vision Video Laryngoscope

December 18, 2023 updated by: Başar Erdivanlı, Recep Tayyip Erdogan University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

388

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

  • Turkey
      • Rize, Turkey, 53100
        • Recep Tayyip Erdoğan University

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

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: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Macintosh
Patients scheduled for general anesthesia during the study period, who had been intubated with Macintosh laryngoscope first and then with KingVision videolaryngoscope.
Device: Macintosh laryngoscope
Using a Macintosh laryngoscope, time to glottic view, best Cormack-Lehane grade, time to intubation, time to first ventilation has been recorded.
Device: King Vision video laryngoscope
Using a King Vision video laryngoscope, time to glottic view, best Cormack-Lehane grade, time to intubation, time to first ventilation has been recorded.
Active Comparator: KingVision
Patients scheduled for general anesthesia during the study period, who had been intubated with King Vision videolaryngoscope first and then with Macintosh laryngoscope.
Device: Macintosh laryngoscope
Using a Macintosh laryngoscope, time to glottic view, best Cormack-Lehane grade, time to intubation, time to first ventilation has been recorded.
Device: King Vision video laryngoscope
Using a King Vision video laryngoscope, time to glottic view, best Cormack-Lehane grade, time to intubation, time to first ventilation has been recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubation Success Rate
Time Frame: less than 24 hours
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].
less than 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubation Time
Time Frame: less than 24 hours
Successful endotracheal intubation is defined as the endotracheal cuff passing the patient's vocal cords. Time to intubation with each laryngoscope is recorded.
less than 24 hours
Cormack-Lehane Score
Time Frame: less than 24 hours

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):

  1. full view of glottis (difficult intubation unlikely)
  2. partial view of glottis (~5% risk of difficult intubation)
  3. partial view of epiglottis, none of glottis seen (~90% risk of difficult intubation)
  4. neither glottis nor epiglottis seen (difficult intubation very likely)
less than 24 hours
Airway Complications
Time Frame: The participants' will be followed for the duration of hospital stay, an expected average of 2 days
Any complication related to the laryngoscopy and intubation, such as cut, bleeding, damage to the teeth, laryngospasm, bronchospasm, desaturation below 90%, is recorded.
The participants' will be followed for the duration of hospital stay, an expected average of 2 days
Glottic View Time
Time Frame: less than 24 hours

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 difficult an intubation will be.

It consists of 4 grades:

  1. full view of glottis (difficult intubation unlikely)
  2. partial view of glottis (~5% risk of difficult intubation)
  3. partial view of epiglottis, none of glottis seen (~90% risk of difficult intubation)
  4. neither glottis nor epiglottis seen (difficult intubation very likely)
less than 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Recep Tayyip Erdogan University

Investigators

  • Principal Investigator: Başar Erdivanli, Asst. Prof., Recep Tayyip Erdogan Univeristy, Medical Faculty, Department of Anesthesiology and Reanimation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2014

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

June 22, 2015

First Submitted That Met QC Criteria

June 25, 2015

First Posted (Estimated)

June 26, 2015

Study Record Updates

Last Update Posted (Actual)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 18, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/109

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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