NCT03126344

Brief Summary

This study was designed to determine the comparison between the King Vision video laryngoscope 、 McGrath MAC video laryngoscope and Macintosh laryngoscope for nasotracheal intubation.Patients were divided into 3 groups of 30 patients each.Patients of King Vision group \[n=30\]、 McGrath MAC group \[n=30\] and Macintosh group\[n=30\]were intubated using respective devices.This study is the first to search the use of King Vision video laryngoscope for nasotracheal intubation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 24, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2018

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

September 14, 2020

Completed
Last Updated

September 14, 2020

Status Verified

September 1, 2020

Enrollment Period

7 months

First QC Date

April 19, 2017

Results QC Date

June 15, 2020

Last Update Submit

September 11, 2020

Conditions

Keywords

King Vision

Outcome Measures

Primary Outcomes (1)

  • Time to Intubation

    the interval between opening the mouth and the time when three consecutive end-tidal CO2 waves were appeared on the monitor

    0 min after nasal intubation

Secondary Outcomes (2)

  • Laryngoscopy Time

    after expose the glottis

  • Number of Participants With Complications

    24h after surgery

Study Arms (3)

King Vision video laryngoscope

EXPERIMENTAL
Device: King Vision video laryngoscope

McGrath MAC video laryngoscope

EXPERIMENTAL
Device: McGrath MAC video laryngoscope

Macintosh

ACTIVE COMPARATOR
Device: Macintosh laryngoscope

Interventions

nasal intubation using King Vision video laryngoscope Device after general anesthesia induction

King Vision video laryngoscope

nasal intubation using McGrath MAC video laryngoscope Device after general anesthesia induction

McGrath MAC video laryngoscope

nasal intubation using Macintosh laryngoscope Device after general anesthesia induction

Macintosh

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ASA physical status 1-2
  • general anesthesia with nasotracheal intubation
  • anticipated difficult airway

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Ninth People's Hospital,Affililated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200011, China

Location

Related Publications (1)

  • Zhu H, Liu J, Suo L, Zhou C, Sun Y, Jiang H. A randomized controlled comparison of non-channeled king vision, McGrath MAC video laryngoscope and Macintosh direct laryngoscope for nasotracheal intubation in patients with predicted difficult intubations. BMC Anesthesiol. 2019 Aug 31;19(1):166. doi: 10.1186/s12871-019-0838-z.

Results Point of Contact

Title
Sun Yu
Organization
Shanghai ninth people's hospital

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 19, 2017

First Posted

April 24, 2017

Study Start

June 1, 2017

Primary Completion

January 1, 2018

Study Completion

January 5, 2018

Last Updated

September 14, 2020

Results First Posted

September 14, 2020

Record last verified: 2020-09

Locations