Difficult IntubationNCT02324465
King Vision Video Laryngoscope Versus Glidescope Video Laryngoscope
A study testing King Vision Video Laryngoscope and Glidescope Video Laryngoscope in people with Difficult Intubation, run by Vanderbilt University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Difficult Intubation
- What is being tested?
- King Vision Video Laryngoscope and Glidescope Video Laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Oct 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients scheduled for elective, ambulatory surgery requiring general anesthesia and endotracheal intubation
Who cannot join
- Patients who require rapid sequence induction and intubation or fiberoptic intubation.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: King Vision Video Laryngoscope Versus Glidescope Video Laryngoscope: A Comparative Study in Ambulatory Surgery Center Patients
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.
Read the detailed description
Both the King Vision and Glidescope video laryngoscopes are advanced airway devices that are relatively low cost and are designed to improve the efficiency of both routine and difficult intubation. Both systems use disposable blades, which eliminates the need for blade sterilization and may minimize the risk of infectious exposure to patients and improve cost and efficiency associated with the sterilization processing of non-disposable laryngoscopes. The Glidescope has been commercially available longer than the King Vision, and has been more frequently studied.
Although similar in many respects, the King Vision and Glidescope systems have differing designs which may result in differences in speed and success in the management of routine and/or difficult airways.
- Conditions
- Difficult Intubation
- Being tested
- King Vision Video Laryngoscope, Glidescope Video Laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
King Vision Video LaryngoscopeDevice
Also called King Systems
Intubation via King Vision Video Laryngoscope
Glidescope Video LaryngoscopeDevice
Also called Verathon
Intubation via Glidescope Video Laryngoscope
| Study group | Role | What they receive |
|---|---|---|
| King Vision Video Laryngoscope | Active comparator | The patient would be randomized to intubation via use of the King Vision VL Receives: Device: King Vision Video Laryngoscope |
| Glidescope Video Laryngoscope | Active comparator | The patient would be randomized to intubation via use of the Glidescope VL Receives: Device: Glidescope Video Laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Until Intubation With Each Device
time from the introduction of the laryngoscope into the oral cavity to endotracheal tube reaching the glottic aperture
Measured: <100 seconds
Secondary outcomes (2)
Mean Pulse Oximetry Saturation Value Reading During Intubation
Measured: <100 seconds
Total Number of Assisted Maneuvers Required to Complete Intubation (Includes All Participants in Arm)
Assisted Maneuvers can include laryngeal manipulation, head lift, Backward Upward Rightward Pressure, stylet removed, Cricoid pressure, scope manipulation and bougie.
Measured: <100 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startApr 2013
- Primary completionOct 2017
- Study completionOct 2017
Why it stopped: Closed due to low enrollment
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 Difficult IntubationStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doug Hester, Vanderbilt University
- Investigators
- Douglas Hester, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324465
- Sponsor's protocol ID
- 130470
- Status last verified
- Apr 2019
- First submitted
- 18 Dec 2014
- Last updated
- 23 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- King Vision Video Laryngoscope Versus Glidescope Video Laryngoscope: A Comparative Study in Ambulatory Surgery Center Patients
- ClinicalTrials.gov ID
- NCT02324465
- Acronym / sponsor ID
- 130470
- Conditions
- Difficult Intubation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed due to low enrollment
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 24 Dec 2014 (estimated)
- Results
- Posted 23 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Both the King Vision and Glidescope video laryngoscopes are advanced airway devices that are relatively low cost and are designed to improve the efficiency of both routine and difficult intubation. Both systems use disposable blades, which eliminates the need for blade sterilization and may minimize the risk of infectious exposure to patients and improve cost and efficiency associated with the sterilization processing of non-disposable laryngoscopes. The Glidescope has been commercially available longer than the King Vision, and has been more frequently studied.
Although similar in many respects, the King Vision and Glidescope systems have differing designs which may result in differences in speed and success in the management of routine and/or difficult airways.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| King Vision Video Laryngoscope | Active comparator | Device: King Vision Video LaryngoscopeThe patient would be randomized to intubation via use of the King Vision VL |
| Glidescope Video Laryngoscope | Active comparator | Device: Glidescope Video LaryngoscopeThe patient would be randomized to intubation via use of the Glidescope VL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients scheduled for elective, ambulatory surgery requiring general anesthesia and endotracheal intubation
Key exclusion criteria (2 listed)
- Patients who require rapid sequence induction and intubation or fiberoptic intubation.
- Pregnancy
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 LaryngoscopeAlso: King SystemsIntubation via King Vision Video Laryngoscope | Device | King Vision Video Laryngoscope |
| Glidescope Video LaryngoscopeAlso: VerathonIntubation via Glidescope Video Laryngoscope | Device | Glidescope Video Laryngoscope |
Primary outcome
Time Until Intubation With Each Device
Time frame: <100 seconds
time from the introduction of the laryngoscope into the oral cavity to endotracheal tube reaching the glottic aperture
2 secondary outcomes
Mean Pulse Oximetry Saturation Value Reading During Intubation
Time frame: <100 seconds
Total Number of Assisted Maneuvers Required to Complete Intubation (Includes All Participants in Arm)
Time frame: <100 seconds
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Douglas Hester, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing King Vision Video Laryngoscope and Glidescope Video Laryngoscope in people with Difficult Intubation, run by Vanderbilt University at 1 site in United States.
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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 23 Apr 2019). 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?
Time Until Intubation With Each Device (time frame: <100 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 23 Apr 2019.