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Comparison of Different Video Laryngoscopes in Infants Undergoing Neurosurgery: a Prospective Randomized Clinical Trial

Sponsor
Kocaeli University (Other)
Overall Status
Completed
CT.gov ID
NCT04153370
Collaborator
(none)
60
Enrollment
1
Location
3
Arms
3
Actual Duration (Months)
19.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

difficult intubation is high in the 0-1 year period. Video laryngoscopes improved intubation success rate when compared to direct laryngoscopy.

We compared the Airtraq, Glidescope, and c-mac video laryngoscopes during intubation of <1 year old children undergoing neurosurgery.

Condition or Disease Intervention/Treatment Phase
  • Device: Airtraq
  • Device: glidescope
  • Device: c-mac
 N/A

Detailed Description

Aim: difficult intubation is high in the 0-1 year period. Video laryngoscopes improved intubation success rate when compared to direct laryngoscopy.

Methods: We enroll 20 patients age under 1 year old undergoing neurosurgery in this prospective randomized study. We compared the Airtraq, Glidescope, and c-mac video laryngoscopes during intubation of <1 year old children undergoing neurosurgery regarding intubation times and intubation success rates.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Diagnostic
Official Title:
Comparison of Airtraq, Glidescope and C-mac in Infants
Actual Study Start Date :
Nov 5, 2019
Actual Primary Completion Date :
Feb 5, 2020
Actual Study Completion Date :
Feb 5, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: intubation time airtraq

inserting the device through the oral cavity till the visualization of the endotracheal tube passing through the vocal cords

Device: Airtraq
airtraq video laryngoscope was used for intubation of the infant
Other Names:
  • videolaryngoscope

    		•
    Active Comparator: intubation time glidescope

    inserting the device through the oral cavity till the visualization of the endotracheal tube passing through the vocal cords

    Device: glidescope
    glidescope video laryngoscope was used for intubation of the infant
    Other Names:
  • videolaryngoscope

    		•
    Active Comparator: intubation time c-mac

    inserting the device through the oral cavity till the visualization of the endotracheal tube passing through the vocal cords

    Device: c-mac
    c-mac video laryngoscope was used for intubation of the infant
    Other Names:
  • videolaryngoscope

    		•

    Outcome Measures

    Primary Outcome Measures

    1. intubation time [40 seconds]

      device entering the oral cavity till visualization of the tube entering through the vocal cords

    Secondary Outcome Measures

    1. insertion time [20 seconds]

      device entering the oral cavity till the optimal visualization

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 1 Year
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria:,

    • 0-1 age

    • undergoing neurosurgery

    • ASA 1-2

    Exclusion Criteria:

    • cardiac problems

    • ASA 3-4

    • emergency

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kocaeli University Medical Faculty Kocaeli Turkey

    Sponsors and Collaborators

    • Kocaeli University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zehra Ipek ARSLAN, Associate Professor, Kocaeli University
    ClinicalTrials.gov Identifier:
    NCT04153370
    Other Study ID Numbers:
    • KOU KAEK 2015/311
    First Posted:
    Nov 6, 2019
    Last Update Posted:
    Feb 20, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Zehra Ipek ARSLAN, Associate Professor, Kocaeli University
    airtraq
    glidescope
    c-mac
    videolaryngoscope
    intubation
    infant

    Study Results

    No Results Posted as of Feb 20, 2020