NCT03677505

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

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

First Submitted

Initial submission to the registry

September 18, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2018

Completed
16 days until next milestone

Study Start

First participant enrolled

October 5, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2020

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2020

Completed
Last Updated

March 11, 2020

Status Verified

March 1, 2020

Enrollment Period

1.4 years

First QC Date

September 18, 2018

Last Update Submit

March 9, 2020

Conditions

Intubation

Keywords

double lumen intubationvideolaryngoscope

Outcome Measures

Primary Outcomes (1)

  • Intubation time

    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)

Study Arms (2)

KoMAC group

EXPERIMENTAL

Orotracheal intubation with KoMAC videolaryngoscope

Device: KoMAC videolaryngoscope

Macintosh group

ACTIVE COMPARATOR

Orotracheal intubation with Macintosh laryngoscope

Device: Macintosh Laryngoscope

Interventions

KoMAC videolaryngoscopeDEVICE

Double lumen endotracheal intubation was performed with the KoMAC videolaryngoscope

KoMAC group
Macintosh LaryngoscopeDEVICE

Double lumen endotracheal intubation was performed with the Macintosh Laryngoscope

Macintosh group

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients scheduled for thoracic surgery requiring one lung ventilation

You may not qualify if:

  • predicted difficult airway
  • rapid sequence intubation
  • cervical injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou University Hospital

Suwon, Gyeonggi-do, 16499, South Korea

Location

Study Officials

  • Jong Yeop Kim

    Ajou University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 18, 2018

First Posted

September 19, 2018

Study Start

October 5, 2018

Primary Completion

February 27, 2020

Study Completion

March 2, 2020

Last Updated

March 11, 2020

Record last verified: 2020-03

Locations

KR(1)