A Comparison of McGrath MAC®, Pentax-AWS® and Macintosh Direct Laryngoscopes for Nasotracheal Intubation

July 23, 2019 updated by: In-kyong Yi, Ajou University School of Medicine
A comparison of intubation time, difficulty of intubation in nasotracheal intubation using McGrath MAC®, Pentax-AWS® and Macintosh direct laryngoscopes

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This trial is prospective randomized trial. The Objects are adult patients who need nasotracheal intubation for surgery. Using computed randomized table, participants are assigned to three groups, McGrath MAC®, Pentax-AWS® and Macintosh direct laryngoscopes.

The intubation will be done by One expert anesthesiologist who have more than 10 years experience.

Investigators compare intubation time, success rate and difficulty between three groups.

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, Korea, Republic of, 16499
        • Ajou university schoole of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Macintosh
intubation using Macintosh direct laryngoscope
Device: Macintosh
Macintosh direct laryngoscope
Experimental: McGrath
intubation using McGrath MAC®
Device: McGrath
McGrath videolaryngoscope
Experimental: Pentax
intubation using Pentax-airway scope®
Device: Pentax
Pentax videolaryngoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubation time
Time Frame: within 5 minutes
from endotracheal tube pass the nostril to end-tidal CO2 appear
within 5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate
Time Frame: within 5 minutes
Failure defined intubation time more than 120sec or SaO2 less than 95%
within 5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ajou University School of Medicine

Investigators

  • Principal Investigator: Yun Jeong Chae, MD, Ajou University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2017

Primary Completion (Actual)

January 30, 2018

Study Completion (Actual)

February 20, 2018

Study Registration Dates

First Submitted

November 6, 2017

First Submitted That Met QC Criteria

November 7, 2017

First Posted (Actual)

November 9, 2017

Study Record Updates

Last Update Posted (Actual)

July 25, 2019

Last Update Submitted That Met QC Criteria

July 23, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • AJIRB-MED-OBS-17-327

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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