KoMAC Videolaryngoscope for Double-lumen Intubation

March 9, 2020 updated by: Jong Yeop Kim, Ajou University School of Medicine

Comparison of the KoMAC Videolaryngoscope With the Macintosh Laryngoscope for Double-lumen Intubation

KoMAC videolaryngoscope is a portable intubating device with an angulated single-use blade of adjustable size and a liquid crystal display monitor mounted on top of the handle, which is similar in shape to the McGrath videolaryngoscope. The purpose of this study was to evaluate the efficacy of the KoMAC videolaryngoscope for double-lumen intubation regarding intubation time, laryngeal view and ease of intubation, compared to Macintosh laryngoscope.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

  • Korea, Republic of
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, Korea, Republic of, 16499
        • Ajou University Hospital

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

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients scheduled for thoracic surgery requiring one lung ventilation

Exclusion Criteria:

  • predicted difficult airway
  • rapid sequence intubation
  • cervical injury

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: KoMAC group
Orotracheal intubation with KoMAC videolaryngoscope
Device: KoMAC videolaryngoscope
Double lumen endotracheal intubation was performed with the KoMAC videolaryngoscope
Active Comparator: Macintosh group
Orotracheal intubation with Macintosh laryngoscope
Device: Macintosh Laryngoscope
Double lumen endotracheal intubation was performed with the Macintosh Laryngoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubation time
Time Frame: from 2 min after rocuronium injection to completion of intubation (time interval is about 120 seconds)
Time interval between laryngoscope passing the teeth to the confirming of end tidal CO2
from 2 min after rocuronium injection to completion of intubation (time interval is about 120 seconds)

Collaborators and Investigators

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

Sponsor

Ajou University School of Medicine

Investigators

  • Principal Investigator: Jong Yeop Kim, 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)

October 5, 2018

Primary Completion (Actual)

February 27, 2020

Study Completion (Actual)

March 2, 2020

Study Registration Dates

First Submitted

September 18, 2018

First Submitted That Met QC Criteria

September 18, 2018

First Posted (Actual)

September 19, 2018

Study Record Updates

Last Update Posted (Actual)

March 11, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AJIRB-MED-OBS-18-286

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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