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

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: Intubation;Difficult
• Intervention / Treatment: Device: Macintosh; Device: McGrath; Device: Pentax

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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	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	Failure defined intubation time more than 120sec or SaO2 less than 95%	within 5 minutes

Collaborators and Investigators

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

Study record dates

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