A Comparison of McGrath MAC Videolaryngoscopy and Macintosh Laryngoscopy for Orotracheal Intubation in Children With Torticollis

July 1, 2019 updated by: Ji Eun Kim, Ajou University School of Medicine

Ajou University School of Medicine

The primary purpose of this study is to investigate the effects of McGrath MAC videolaryngoscopy on the intubation time for orotracheal intubation in children with torticollis.

The secondary purpose of this study is to investigate the effects of McGrath MAC videolaryngoscopy on Cormack and Lehane Grade for orotracheal intubation in children with torticollis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

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

  • Korea, Republic of
    • Seoum
      • Suwon, Seoum, Korea, Republic of
        • Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine

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

1 year to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • orotracheal intubation under general anesthesia
  • torticollis

Exclusion Criteria:

  • •oral lesions, congenital anomaly, cervical spine instability, rapid sequence intubation

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mcgrath group
Orotracheal intubation with McGrath MAC videolaryngoscopy
Device: McGrath MAC videolaryngoscopy
Orotracheal intubation with McGrath MAC videolaryngoscopy after anesthetic induction
Placebo Comparator: Macintosh group
Orotracheal intubation with Macintosh laryngoscopy
Device: Macintosh Laryngoscopy
Orotracheal intubation with Macintosh Laryngoscopy after anesthetic induction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubation time
Time Frame: through intubation completion, an average of 30 second
Time interval between laryngoscopy passing the teeth to the confirming of end tidal CO2
through intubation completion, an average of 30 second

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The degree of glottic exposure as assessed by Cormack and Lehane Grade
Time Frame: Up to 5 second after laryngoscopy passing the teeth
Grade 1: full view of glottis, grade 2: Partial view of glottis, grade 3:only epiglottis seen, grade 4:neither glottis nor epiglottis seen
Up to 5 second after laryngoscopy passing the teeth

Collaborators and Investigators

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

Sponsor

Ajou University School of Medicine

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)

May 31, 2018

Primary Completion (Actual)

May 25, 2019

Study Completion (Actual)

May 25, 2019

Study Registration Dates

First Submitted

June 28, 2018

First Submitted That Met QC Criteria

June 28, 2018

First Posted (Actual)

July 11, 2018

Study Record Updates

Last Update Posted (Actual)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 1, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • AJIRB-MED-OBS-18-106

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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