NCT03582787

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 with torticollis. 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 with torticollis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 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

Study Start

First participant enrolled

May 31, 2018

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 11, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2019

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

12 months

First QC Date

June 28, 2018

Last Update Submit

July 1, 2019

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

Device: Macintosh Laryngoscopy

Interventions

McGrath MAC videolaryngoscopyDEVICE

Orotracheal intubation with McGrath MAC videolaryngoscopy after anesthetic induction

Mcgrath group
Macintosh LaryngoscopyDEVICE

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
  • torticollis

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
Assistant professor

Study Record Dates

First Submitted

June 28, 2018

First Posted

July 11, 2018

Study Start

May 31, 2018

Primary Completion

May 25, 2019

Study Completion

May 25, 2019

Last Updated

July 5, 2019

Record last verified: 2019-07

Locations

KR(1)