A Comparison of McGrath MAC®, Pentax-AWS® and Macintosh D... | NCT03337555

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

NCT03337555

Sponsor

Ajou University School of Medicine

Status

Completed

Last Update Posted

Jul 25, 2019Actual

Enrollment

123Actual

Phase

Not Applicable

Conditions

Intubation;Difficult

Interventions

McGrath
Pentax
Macintosh

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 7, 2017Actual

Primary Completion Date

Jan 30, 2018Actual

Completion Date

Feb 20, 2018Actual

First Submitted Date

Nov 6, 2017

First Submission Date that Met QC Criteria

Nov 7, 2017

First Posted Date

Nov 9, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2019

Last Update Posted Date

Jul 25, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

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

Lead Sponsor

Ajou University School of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

123Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
McGrath	Device	McGrath videolaryngoscope	McGrath
Pentax

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yun Jeong Chae, MD	Ajou University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ajou university schoole of medicine		Suwon	Gyeonggi-do	16499	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided