- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02316769
Comparison Study of the McGrath MAC Video Laryngoscope With the King Vision
January 19, 2017 updated by: Bret Alvis, Vanderbilt University Medical Center
Randomized Controlled Trial Comparing the McGrath MAC Video Laryngoscope With the King Vision Video Laryngoscope in Adult Patients.
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Not Applicable
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 and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All interested airway providers (Residents, Attendings, Certified Nurse Anesthetist and
- Student Registered Nurse Anesthetist) will be eligible to be included. -
Exclusion Criteria:
- 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).
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
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: King Vision Video Laryngoscope
Patient intubated with the King Vision Video Laryngoscope
|
Patient intubated with the King Vision Video Laryngoscope
|
Active Comparator: McGrath MAC Video Laryngoscope
Patient intubated with the McGrath MAC Video Laryngoscope
|
Intubation with the McGrath MAC video laryngoscope
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Intubation Success on First Attempt as Measured by End Tidal Carbon Dioxide
Time Frame: participants were followed up to the point the video device is removed from the airway, classified as under 90 seconds.
|
participants were followed up to the point the video device is removed from the airway, classified as under 90 seconds.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Intubation
Time Frame: 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.
|
Number of patients intubated in less than 90 seconds
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Bret Alvis, Vanderbilt 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
August 1, 2012
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
September 5, 2014
First Submitted That Met QC Criteria
December 12, 2014
First Posted (Estimate)
December 15, 2014
Study Record Updates
Last Update Posted (Actual)
March 10, 2017
Last Update Submitted That Met QC Criteria
January 19, 2017
Last Verified
July 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 120884
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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