NCT02324465

Brief Summary

The investigators plan to conduct a randomized trial comparing the intubation success rate and time of the King Vision Video Laryngoscope to the Glidescope video laryngoscope in order to demonstrate the comparability of the devices.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

April 1, 2013

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 24, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

April 23, 2019

Completed
Last Updated

April 23, 2019

Status Verified

April 1, 2019

Enrollment Period

4.5 years

First QC Date

December 18, 2014

Results QC Date

May 22, 2018

Last Update Submit

April 1, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time Until Intubation With Each Device

    time from the introduction of the laryngoscope into the oral cavity to endotracheal tube reaching the glottic aperture

    <100 seconds

Secondary Outcomes (2)

  • Mean Pulse Oximetry Saturation Value Reading During Intubation

    <100 seconds

  • Total Number of Assisted Maneuvers Required to Complete Intubation (Includes All Participants in Arm)

    <100 seconds

Other Outcomes (1)

  • Number of Participants With Adverse Events

    during and immediately after procedure (approx 180 minutes)

Study Arms (2)

King Vision Video Laryngoscope

ACTIVE COMPARATOR

The patient would be randomized to intubation via use of the King Vision VL

Device: King Vision Video Laryngoscope

Glidescope Video Laryngoscope

ACTIVE COMPARATOR

The patient would be randomized to intubation via use of the Glidescope VL

Device: Glidescope Video Laryngoscope

Interventions

Intubation via King Vision Video Laryngoscope

Also known as: King Systems
King Vision Video Laryngoscope

Intubation via Glidescope Video Laryngoscope

Also known as: Verathon
Glidescope Video Laryngoscope

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients scheduled for elective, ambulatory surgery requiring general anesthesia and endotracheal intubation

You may not qualify if:

  • Patients who require rapid sequence induction and intubation or fiberoptic intubation.
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Limitations and Caveats

Study terminated early due to clinical equipoise

Results Point of Contact

Title
Doug Hester
Organization
Vanderbilt University Medical Center

Study Officials

  • Douglas Hester, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 18, 2014

First Posted

December 24, 2014

Study Start

April 1, 2013

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

April 23, 2019

Results First Posted

April 23, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations