NCT02828631

Brief Summary

Videolaryngoscope provide better view of the larynx. This better view could improve the navigation of endotracheal tube in nasotracheal intubation. Contrast to the improved result in adult, one previous report using Glidescope in children did not show better performance than direct laryngoscope. The aim of this study is to compare the performance of McGrath, Pentax and Macintosh laryngoscope for nasotracheal intubation in children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

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

June 30, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

January 10, 2019

Status Verified

January 1, 2019

Enrollment Period

1.3 years

First QC Date

June 30, 2016

Last Update Submit

January 8, 2019

Conditions

Intubation TimeIntubation Difficulty Scale

Outcome Measures

Primary Outcomes (1)

  • time to intubation

    Time from nasotracheal tube passing nose until confirmation of tracheal intubation by end-tidal carbon dioxide will be measured

    2 min

Secondary Outcomes (1)

  • intubation difficulty scale

    immediately after intubation

Study Arms (3)

Macintosh laryngoscope

ACTIVE COMPARATOR

Nasotracheal intubation by Macintosh laryngoscope

Device: Macintosh laryngoscope

McGrath videolaryngoscope

EXPERIMENTAL

Nasotracheal intubation by McGrath videolaryngoscope

Device: McGrath videolaryngoscope

Pentax videolaryngoscope

EXPERIMENTAL

Nasotracheal intubation by Pentax videolaryngoscope

Device: Pentax videolaryngoscope

Interventions

Macintosh laryngoscopeDEVICE
Macintosh laryngoscope
McGrath videolaryngoscopeDEVICE
McGrath videolaryngoscope
Pentax videolaryngoscopeDEVICE
Pentax videolaryngoscope

Eligibility Criteria

Age1 Year - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • American Society of Anesthesiologist physical status class I, II

You may not qualify if:

  • abnormality of airway
  • bleeding tendency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou universitiy school of medicine

Suwon, Gyeong-gi Do, 16499, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 30, 2016

First Posted

July 11, 2016

Study Start

July 1, 2016

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

January 10, 2019

Record last verified: 2019-01

Locations

KR(1)