NCT02647606

Brief Summary

Videolaryngoscope is useful to improve the laryngeal view, especially during difficult intubation. There are several kinds of videolaryngoscopes and it is applicable during nasotracheal intubation. In this study, the investigators will compare the McGrath videolaryngoscope and Pentax-AWS with Macintosh laryngoscope for nasotracheal intubation in patients with manual in-line stabilization.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

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

December 28, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

November 6, 2018

Status Verified

November 1, 2018

Enrollment Period

1.1 years

First QC Date

December 28, 2015

Last Update Submit

November 4, 2018

Conditions

Oral SurgeryMaxillofacial Surgery

Outcome Measures

Primary Outcomes (3)

  • time for intubation

    from holding the laryngoscope until the 1st ventilation after intubation, within 90 seconds

  • Cormack Lehane Laryngeal view

    when laryngoscope is appropriately placed during intubation, approximately 2 seconds

  • POGP score

    Percentage of glottic opening(POGO)

    when laryngoscope is appropriately placed during intubation, approximately 2 seconds

Secondary Outcomes (5)

  • external laryngeal manipulation

    when laryngoscope is appropriately placed during intubation, approximately 2 seconds

  • magill forceps

    when laryngoscope is appropriately placed during intubation, approximately 5 seconds

  • IDS (intubation difficulty scale)

    during intubation, approximately 90 seconds

  • numeric rating scale for intubation

    during intubation, approximately 90 seconds

  • grade of bleeding

    10 seconds after completion of intubation

Study Arms (3)

McGrath Group

EXPERIMENTAL

MgGrath videolaryngoscope will be used for nasotracheal intubation with MILS

Procedure: MILSDevice: McGrath videolaryngoscope

Pentax-AWS Group

EXPERIMENTAL

Pentax-AWS videolaryngoscope will be used for nasotracheal intubation with MILS

Procedure: MILSDevice: Pentax AWS videolaryngoscope

Macintosh Laryngoscope Group

EXPERIMENTAL

Macintosh Laryngoscope will be used for nasotracheal intubation with MILS

Procedure: MILSDevice: Macintosh laryngoscope

Interventions

MILSPROCEDURE

MILS(Manual in-line stabilization) will be applied during intubation. With MILS, different kinds of laryngoscope will be evaluated in a simulated difficult airway.

Macintosh Laryngoscope GroupMcGrath GroupPentax-AWS Group
McGrath videolaryngoscopeDEVICE

McGrath videolaryngoscope will be used for intubation

McGrath Group
Pentax AWS videolaryngoscopeDEVICE

Pentax AWS videolaryngoscope will be used for intubation

Pentax-AWS Group
Macintosh laryngoscopeDEVICE

Macintosh laryngoscope will be used for intubation

Macintosh Laryngoscope Group

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • oral or maxillofacial surgery
  • ASA class I, II

You may not qualify if:

  • anticipated difficult intubation
  • necessity for rapid sequence induction
  • cervical spine injury
  • bleeding tendency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Roh GU, Kwak HJ, Lee KC, Lee SY, Kim JY. Randomized comparison of McGrath MAC videolaryngoscope, Pentax Airway Scope, and Macintosh direct laryngoscope for nasotracheal intubation in patients with manual in-line stabilization. Can J Anaesth. 2019 Oct;66(10):1213-1220. doi: 10.1007/s12630-019-01409-5. Epub 2019 May 29.

    PMID: 31144258DERIVED

Study Officials

  • Go Un Roh, MD

    Ajou University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

December 28, 2015

First Posted

January 6, 2016

Study Start

January 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

November 6, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share