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

Sponsor

Ajou University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT03337555

Collaborator

(none)

123

Enrollment

Location

Arms

3.4

Actual Duration (Months)

35.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Intubation;Difficult	Device: McGrath Device: Pentax Device: Macintosh	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

123 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Nov 7, 2017

Actual Primary Completion Date :

Jan 30, 2018

Actual Study Completion Date :

Feb 20, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Intubation time [within 5 minutes]
from endotracheal tube pass the nostril to end-tidal CO2 appear

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ajou university schoole of medicine	Suwon	Gyeonggi-do	Korea, Republic of	16499

Sponsors and Collaborators

Ajou University School of Medicine

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

In-kyong Yi, Clinical assitant professor, Ajou University School of Medicine

ClinicalTrials.gov Identifier:

NCT03337555

Other Study ID Numbers:

AJIRB-MED-OBS-17-327

First Posted:

Nov 9, 2017

Last Update Posted:

Jul 25, 2019

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 25, 2019