NCT03129399

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 26, 2017

Completed
24 days until next milestone

Study Start

First participant enrolled

May 20, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2018

Completed
Last Updated

May 23, 2017

Status Verified

May 1, 2017

Enrollment Period

1 year

First QC Date

April 14, 2017

Last Update Submit

May 20, 2017

Conditions

Keywords

anesthesiaKing Visionvideolaryngoscopenasotracheal

Outcome Measures

Primary Outcomes (1)

  • time to intubation

    from taking of the intubation device to successful intubation

    0 min after nasal intubation

Secondary Outcomes (9)

  • Hemodynamic changes

    1 min before general anesthesia induction

  • Hemodynamic changes

    1 min after general anesthesia induction

  • Hemodynamic changes

    3 min after general anesthesia induction

  • Hemodynamic changes

    5 min after general anesthesia induction

  • ease of intubation

    5 min after nasal intubation

  • +4 more secondary outcomes

Study Arms (2)

King Vision video laryngoscope

EXPERIMENTAL
Device: King Vision video laryngoscope

McGrath MAC video laryngoscope

ACTIVE COMPARATOR
Device: McGrath MAC video laryngoscope

Interventions

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

King Vision video laryngoscope

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

McGrath MAC video laryngoscope

Eligibility Criteria

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

You may qualify if:

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

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

RECRUITING

Central Study Contacts

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 14, 2017

First Posted

April 26, 2017

Study Start

May 20, 2017

Primary Completion

May 20, 2018

Study Completion

June 20, 2018

Last Updated

May 23, 2017

Record last verified: 2017-05

Locations