NCT02827123

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

July 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

July 12, 2018

Status Verified

July 1, 2018

Enrollment Period

2 months

First QC Date

July 3, 2016

Last Update Submit

July 10, 2018

Conditions

Anesthesia, Endotracheal

Outcome Measures

Primary Outcomes (1)

  • Intubation time

    Time interval between laryngoscopy passing the teeth to the confirming of end tidal CO2

    through intubation completion, an average of 30 second

Secondary Outcomes (1)

  • The degree of glottic exposure as assessed by Cormack and Lehane Grade

    Up to 5 second after laryngoscopy passing the teeth

Study Arms (2)

Mcgrath group

EXPERIMENTAL

Orotracheal intubation with McGrath MAC videolaryngoscopy

Device: McGrath MAC videolaryngoscopy

Macintosh group

PLACEBO COMPARATOR

Orotracheal intubation with Macintosh laryngoscopy

Drug: Macintosh Laryngoscopy

Interventions

McGrath MAC videolaryngoscopyDEVICE

Orotracheal intubation with McGrath MAC videolaryngoscopy after anesthetic induction

Mcgrath group
Macintosh LaryngoscopyDRUG

Orotracheal intubation with Macintosh Laryngoscopy after anesthetic induction

Macintosh group

Eligibility Criteria

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

You may qualify if:

  • orotracheal intubation under general anesthesia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine

Suwon, Seoum, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assitant professor

Study Record Dates

First Submitted

July 3, 2016

First Posted

July 11, 2016

Study Start

July 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

July 12, 2018

Record last verified: 2018-07

Locations

KR(1)