NCT02316769

Brief Summary

In this study, the investigators compare the effectiveness of two relatively new video laryngoscopes, McGrath MAC (Covidien, Dublin Ireland) and the King Vision (King Systems, Noblesville, IN), by practitioners experienced in airway management but with limited exposure to these two devices. Our hypothesis was that, the McGrath MAC device would require fewer intubation attempts and shorter intubation times than the King Vision when performed by novice users.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2012

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

August 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 15, 2014

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

August 24, 2016

Completed
Last Updated

March 10, 2017

Status Verified

July 1, 2016

Enrollment Period

9 months

First QC Date

September 5, 2014

Results QC Date

July 24, 2015

Last Update Submit

January 19, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Intubation Success on First Attempt as Measured by End Tidal Carbon Dioxide

    participants were followed up to the point the video device is removed from the airway, classified as under 90 seconds.

Secondary Outcomes (1)

  • Time to Intubation

    Intubation time was initiated at the time of entry of the study device beyond the teeth/gum line and the intubation time was stopped when the study device was removed beyond the same point.

Study Arms (2)

King Vision Video Laryngoscope

ACTIVE COMPARATOR

Patient intubated with the King Vision Video Laryngoscope

Procedure: King Vision video laryngoscope

McGrath MAC Video Laryngoscope

ACTIVE COMPARATOR

Patient intubated with the McGrath MAC Video Laryngoscope

Procedure: McGrath MAC video laryngoscope

Interventions

Patient intubated with the King Vision Video Laryngoscope

King Vision Video Laryngoscope

Intubation with the McGrath MAC video laryngoscope

McGrath MAC Video Laryngoscope

Eligibility Criteria

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

You may qualify if:

  • All interested airway providers (Residents, Attendings, Certified Nurse Anesthetist and
  • Student Registered Nurse Anesthetist) will be eligible to be included. -

You may not qualify if:

  • All patients with difficult airways as determined by history or physical exam (limited oral opening, limited cervical extension, receding chin, Mallampati class III or IV).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Results Point of Contact

Title
Bret Alvis
Organization
Vanderbilt University

Study Officials

  • Bret Alvis

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

September 5, 2014

First Posted

December 15, 2014

Study Start

August 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

March 10, 2017

Results First Posted

August 24, 2016

Record last verified: 2016-07