NCT02267759

Brief Summary

McGrath videolaryngoscopy avoids the use of Magill forceps for nasotracheal intubation, thereby reducing intubation time and complications, especially in patients with a difficult airway. This study was performed to investigate whether McGrath videolaryngoscopy is superior to Macintosh laryngoscopy for routine nasotracheal intubation in expected normal airways, as judged by the time to intubation and ease of intubation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2014

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 17, 2014

Completed
15 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

June 19, 2015

Status Verified

June 1, 2015

Enrollment Period

4 months

First QC Date

October 14, 2014

Last Update Submit

June 17, 2015

Conditions

Nasotracheal Intubation

Outcome Measures

Primary Outcomes (1)

  • time to intubation

    time the nasotracheal tube was inserted into nares until endtidal CO2 was detected

    4 min after anesthetic induction

Study Arms (2)

McGrath

EXPERIMENTAL

Nasotracheal intubation was performed with McGrath videolaryngoscopy

Device: Macintosh laryngoscopy

Macintosh

ACTIVE COMPARATOR

Nasotracheal intubation was performed with Macintosh direct laryngoscopy

Device: McGrath videolaryngoscopy

Interventions

McGrath videolaryngoscopyDEVICE

After the softened nasotracheal tube was inserted into the nares until its tip passed through the posterior nares, McGrath videolaryngoscope was introduced into the mouth and the nasotracheal tube was advanced.

Macintosh
Macintosh laryngoscopyDEVICE

After the softened nasotracheal tube was inserted into the nares until its tip passed through the posterior nares, Macintosh laryngoscope was introduced into the mouth and the nasotracheal tube was advanced.

McGrath

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients for dental or maxillofacial surgery requiring nasotracheal intubation

You may not qualify if:

  • known difficult airway
  • required rapid sequence induction
  • history of bleeding
  • cervical spine injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou University Hospital

Suwon, Gyeongki-do, 443-721, South Korea

Location

Study Officials

  • Jong Yeop Kim, MD

    Ajou University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 14, 2014

First Posted

October 17, 2014

Study Start

November 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

June 19, 2015

Record last verified: 2015-06

Locations

KR(1)