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

May 20, 2017 updated by: Sun Yu, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Nasal Intubation Using the King Vision Video Laryngoscope:a Randomized,Controlled Comparison With McGrath MAC Video Laryngoscope

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

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

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200011
        • Recruiting
        • Shanghai Ninth People's Hospital,Affililated to Shanghai Jiaotong University School of Medicine
        • Contact:
        • Sub-Investigator:
          • Haozhen Zhu, MM

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

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: King Vision video laryngoscope
Device: King Vision video laryngoscope
nasal intubation using King Vision video laryngoscope Device after general anesthesia induction
Active Comparator: McGrath MAC video laryngoscope
Device: McGrath MAC video laryngoscope
nasal intubation with McGrath MAC video laryngoscope Device after general anesthesia induction

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemodynamic changes
Time Frame: 1 min before general anesthesia induction
heart rate
1 min before general anesthesia induction
Hemodynamic changes
Time Frame: 1 min after general anesthesia induction
heart rate
1 min after general anesthesia induction
Hemodynamic changes
Time Frame: 3 min after general anesthesia induction
heart rate
3 min after general anesthesia induction
Hemodynamic changes
Time Frame: 5 min after general anesthesia induction
heart rate
5 min after general anesthesia induction
ease of intubation
Time Frame: 5 min after nasal intubation
VAS scores
5 min after nasal intubation
incidence of trauma
Time Frame: 24hour after surgery
sore throat, hoarseness, etc
24hour after surgery
incidence of trauma
Time Frame: 1hour after surgery
sore throat, hoarseness, etc
1hour after surgery
number of failures
Time Frame: 5 min after nasal intubation
intubation failure
5 min after nasal intubation
the degree of Cormach-Lehane
Time Frame: 5 min after nasal intubation
glottic exposure
5 min after nasal intubation

Collaborators and Investigators

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

Sponsor

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

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)

May 20, 2017

Primary Completion (Anticipated)

May 20, 2018

Study Completion (Anticipated)

June 20, 2018

Study Registration Dates

First Submitted

April 14, 2017

First Submitted That Met QC Criteria

April 25, 2017

First Posted (Actual)

April 26, 2017

Study Record Updates

Last Update Posted (Actual)

May 23, 2017

Last Update Submitted That Met QC Criteria

May 20, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • suny

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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