Comparison of King Vision Video Laryngoscope to McGrath M... | NCT03129399

Studies
Comparison of King Vision Video Laryngoscope to McGrath MAC Video Laryngoscope for Nasal Intubation

NCT03129399

Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Status

Unknown status

Last Update Posted

May 23, 2017Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Nasal Intubation

Interventions

King Vision video laryngoscope
McGrath MAC video laryngoscope

Countries

China

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

May 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 20, 2017Actual

Primary Completion Date

May 20, 2018Estimated

Completion Date

Jun 20, 2018Estimated

First Submitted Date

Apr 14, 2017

First Submission Date that Met QC Criteria

Apr 25, 2017

First Posted Date

Apr 26, 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

May 20, 2017

Last Update Posted Date

May 23, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sun Yu, Principal Investigator, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityPrincipal Investigator

Lead Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study was designed to determine the comparison between the King Vision video laryngoscope and McGrath MAC video laryngoscope for nasotracheal intubation.Patients were divided into 2 groups of 40 patients each.Patients of King Vision group [n=40]and Macintosh group [n=40]were intubated using respective devices.This study is the first to search the use of King Vision video laryngoscope for nasotracheal intubation in difficult airway.

Detailed Description

Not provided

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

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
King Vision video laryngoscope	Experimental		Device: King Vision video laryngoscope
McGrath MAC video laryngoscope	Active Comparator		Device: McGrath MAC video laryngoscope

Interventions

Name	Type	Description	Arm Group Labels	Other Names
King Vision video laryngoscope	Device	nasal intubation using King Vision video laryngoscope Device after general anesthesia induction	King Vision video laryngoscope

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
time to intubation	from taking of the intubation device to successful intubation	0 min after nasal intubation

Secondary Outcomes

Measure	Description	Time Frame
Hemodynamic changes	heart rate	1 min before general anesthesia induction
Hemodynamic changes	heart rate	1 min after general anesthesia induction

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA physical status 1-2
Scheduled for general anesthesia with nasotracheal intubation
Cormach-Lehane score 3-4

Exclusion Criteria:

contraindications to nasal intubation
Patients with a history of anti-hypertensive drugs

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yu Sun, MD,PhD	Contact	0086-136-1189-5542		dr_sunyu@163.com
Haozhen Zhu, MM	Contact	0086-189-1889-0657		zhuhaozhen921@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Ninth People's Hospital,Affililated to Shanghai Jiaotong University School of Medicine	Recruiting	Shanghai	Shanghai Municipality	200011	China