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

February 19, 2020 updated by: Zehra Ipek ARSLAN, Kocaeli University

Comparison of Airtraq, Glidescope and C-mac in Infants

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

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
      • Kocaeli, Turkey
        • Kocaeli University Medical Faculty

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

No older than 1 year (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:,

  • 0-1 age
  • undergoing neurosurgery
  • ASA 1-2

Exclusion Criteria:

  • cardiac problems
  • ASA 3-4
  • emergency

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: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intubation time
Time Frame: 40 seconds
device entering the oral cavity till visualization of the tube entering through the vocal cords
40 seconds

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
insertion time
Time Frame: 20 seconds
device entering the oral cavity till the optimal visualization
20 seconds

Collaborators and Investigators

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

Sponsor

Kocaeli University

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 (ACTUAL)

November 5, 2019

Primary Completion (ACTUAL)

February 5, 2020

Study Completion (ACTUAL)

February 5, 2020

Study Registration Dates

First Submitted

November 4, 2019

First Submitted That Met QC Criteria

November 4, 2019

First Posted (ACTUAL)

November 6, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 20, 2020

Last Update Submitted That Met QC Criteria

February 19, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KOU KAEK 2015/311

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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