Video Laryngoscopic Device Usage in Novice UsersNCT02316769
Comparison Study of the McGrath MAC Video Laryngoscope With the King Vision
A study testing King Vision video laryngoscope and McGrath MAC video laryngoscope in people with Video Laryngoscopic Device Usage in Novice Users, run by Vanderbilt University Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Video Laryngoscopic Device Usage in Novice Users
- What is being tested?
- King Vision video laryngoscope and McGrath MAC video laryngoscope
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to May 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All interested airway providers (Residents, Attendings, Certified Nurse Anesthetist and
- Student Registered Nurse Anesthetist) will be eligible to be included. -
Who cannot join
- 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).
About this study
Official title: 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.
- Being tested
- King Vision video laryngoscope, McGrath MAC video laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
King Vision video laryngoscopeProcedure or surgery
Patient intubated with the King Vision Video Laryngoscope
McGrath MAC video laryngoscopeProcedure or surgery
Intubation with the McGrath MAC video laryngoscope
| Study group | Role | What they receive |
|---|---|---|
| King Vision Video Laryngoscope | Active comparator | Patient intubated with the King Vision Video Laryngoscope Receives: Procedure: King Vision video laryngoscope |
| McGrath MAC Video Laryngoscope | Active comparator | Patient intubated with the McGrath MAC Video Laryngoscope Receives: Procedure: McGrath MAC video laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation Success on First Attempt as Measured by End Tidal Carbon Dioxide
Measured: 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
Number of patients intubated in less than 90 seconds
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2014 (estimated)
- Study startAug 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Video Laryngoscopic Device Usage in Novice UsersStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bret Alvis, Vanderbilt University Medical Center
- Investigators
- Bret Alvis, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02316769
- Sponsor's protocol ID
- 120884
- Status last verified
- Jul 2016
- First submitted
- 5 Sep 2014
- Last updated
- 10 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing the McGrath MAC Video Laryngoscope With the King Vision Video Laryngoscope in Adult Patients.
- ClinicalTrials.gov ID
- NCT02316769
- Acronym / sponsor ID
- 120884
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 15 Dec 2014 (estimated)
- Results
- Posted 24 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| King Vision Video Laryngoscope | Active comparator | Procedure: King Vision video laryngoscopePatient intubated with the King Vision Video Laryngoscope |
| McGrath MAC Video Laryngoscope | Active comparator | Procedure: McGrath MAC video laryngoscopePatient intubated with the McGrath MAC Video Laryngoscope |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All interested airway providers (Residents, Attendings, Certified Nurse Anesthetist and
- Student Registered Nurse Anesthetist) will be eligible to be included. -
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| King Vision video laryngoscopePatient intubated with the King Vision Video Laryngoscope | Procedure or surgery | King Vision Video Laryngoscope |
| McGrath MAC video laryngoscopeIntubation with the McGrath MAC video laryngoscope | Procedure or surgery | McGrath MAC Video Laryngoscope |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bret Alvis principal investigator
Vanderbilt University
Questions about this trial
What is this clinical trial studying?
A study testing King Vision video laryngoscope and McGrath MAC video laryngoscope in people with Video Laryngoscopic Device Usage in Novice Users, run by Vanderbilt University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2017.