NCT02482870

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
388

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 26, 2015

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

February 22, 2018

Completed
Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

6 months

First QC Date

June 22, 2015

Results QC Date

October 20, 2015

Last Update Submit

December 18, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 / \[the number of attempts\].

    less than 24 hours

Secondary Outcomes (4)

  • Intubation Time

    less than 24 hours

  • Glottic View Time

    less than 24 hours

  • Cormack-Lehane Score

    less than 24 hours

  • Airway Complications

    The participants' will be followed for the duration of hospital stay, an expected average of 2 days

Study Arms (2)

Macintosh

ACTIVE COMPARATOR

Patients scheduled for general anesthesia during the study period, who had been intubated with Macintosh laryngoscope first and then with KingVision videolaryngoscope.

Device: Macintosh laryngoscopeDevice: King Vision video laryngoscope

KingVision

ACTIVE COMPARATOR

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 laryngoscopeDevice: King Vision video laryngoscope

Interventions

Using a Macintosh laryngoscope, time to glottic view, best Cormack-Lehane grade, time to intubation, time to first ventilation has been recorded.

KingVisionMacintosh

Using a King Vision video laryngoscope, time to glottic view, best Cormack-Lehane grade, time to intubation, time to first ventilation has been recorded.

KingVisionMacintosh

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • scheduled for general anesthesia
  • age higher than 18 years
  • age lower than 60 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Recep Tayyip Erdogan University

Rize, 53100, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 21550550BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 11871945BACKGROUND
  • 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.

    PMID: 23812581BACKGROUND
  • 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.

    PMID: 24742495BACKGROUND
  • 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.

    PMID: 24460509BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Limitations and Caveats

Sample size estimation according to small number of participants; sequential intubation with both laryngoscopes providing an advantage to the second laryngoscope.

Results Point of Contact

Title
Dr. Başar Erdivanlı
Organization
Recep Tayyip Erdogan University School of Medicine

Study Officials

  • Başar Erdivanli, Asst. Prof.

    Recep Tayyip Erdogan Univeristy, Medical Faculty, Department of Anesthesiology and Reanimation

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
SEQUENTIAL
Model Details: Patients scheduled for general anesthesia with endotracheal intubation will be randomized to either intubation with Macintosh laryngoscope first or King Vision videolaryngoscope first. All patients will be intubated with both laryngoscopes.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst Prof

Study Record Dates

First Submitted

June 22, 2015

First Posted

June 26, 2015

Study Start

January 1, 2014

Primary Completion

July 1, 2014

Study Completion

November 1, 2014

Last Updated

December 20, 2023

Results First Posted

February 22, 2018

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations