NCT03337555

Brief Summary

A comparison of intubation time, difficulty of intubation in nasotracheal intubation using McGrath MAC®, Pentax-AWS® and Macintosh direct laryngoscopes

Trial Health

87
On Track

Trial Health Score

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

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

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

First Submitted

Initial submission to the registry

November 6, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

November 7, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2018

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2018

Completed
Last Updated

July 25, 2019

Status Verified

July 1, 2019

Enrollment Period

3 months

First QC Date

November 6, 2017

Last Update Submit

July 23, 2019

Conditions

Intubation;Difficult

Outcome Measures

Primary Outcomes (1)

  • Intubation time

    from endotracheal tube pass the nostril to end-tidal CO2 appear

    within 5 minutes

Secondary Outcomes (1)

  • Success rate

    within 5 minutes

Study Arms (3)

Macintosh

ACTIVE COMPARATOR

intubation using Macintosh direct laryngoscope

Device: Macintosh

McGrath

EXPERIMENTAL

intubation using McGrath MAC®

Device: McGrath

Pentax

EXPERIMENTAL

intubation using Pentax-airway scope®

Device: Pentax

Interventions

McGrathDEVICE

McGrath videolaryngoscope

McGrath
PentaxDEVICE

Pentax videolaryngoscope

Pentax
MacintoshDEVICE

Macintosh direct laryngoscope

Macintosh

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 19 years old
  • ASA I or II
  • Patients who need nasotracheal intubation for surgery

You may not qualify if:

  • Anatomical deformity in head and neck
  • Modified Mallampati score IV
  • Bleeding tendency in preoperative evaluation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou university schoole of medicine

Suwon, Gyeonggi-do, 16499, South Korea

Location

Study Officials

  • Yun Jeong Chae, 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
Clinical assitant professor

Study Record Dates

First Submitted

November 6, 2017

First Posted

November 9, 2017

Study Start

November 7, 2017

Primary Completion

January 30, 2018

Study Completion

February 20, 2018

Last Updated

July 25, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)