Intubation, OrotrachealNCT01489605
GlideScope Groove vs. Standard GlideScope: A Non-inferiority Study
A study testing GlideScope Groove in people with Intubation, Orotracheal, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites in Canada.
Trial summary
Patients presenting for elective surgery requiring orotracheal intubation will be randomized to being intubated with either the GlideScope Groove video-laryngoscope or the standard GlideScope video-laryngoscope. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation, Orotracheal
- What is being tested?
- GlideScope Groove
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesCanada
- Study dates
- Jul 2019to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any adult patient booked for elective surgery requiring orotracheal intubation.
Who cannot join
- Any patient with cervical spine abnormalities.
- Any patients with known or probable difficult airways.
- Any patient requiring rapid sequence induction.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
London Health Sciences Center University Hospital
London, Ontario, N6A5A5
London Health Sciences Centre Victoria Campus
London, Ontario, N6A5a5
About this study
Official title: Comparison of GlideScope Groove to Standard GlideScope for Orotracheal Intubation: A Non-inferiority Study
Patients presenting for elective surgery requiring orotracheal intubation will be randomized to being intubated with either the GlideScope Groove video-laryngoscope or the standard GlideScope video-laryngoscope.
Read the detailed description
See above. The primary outcome is time to intubation.
- Conditions
- Intubation, Orotracheal
- Being tested
- GlideScope Groove, Control: Standard GlideScope
- Keywords
- Orotracheal intubation, videolaryngoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlideScope GrooveDevice
Also called Verathon
Patients will be intubated using the GlideScope Groove device. (Verathon)
Control: Standard GlideScopeDevice
Also called Varathon
Patients will be intubated using the standard GlideScope. (Verathon)
| Study group | Role | What they receive |
|---|---|---|
| GlideScope Groove | Experimental | Patients will be intubated using the GlideScope Groove device. (Verathon) Receives: Device: GlideScope Groove |
| Control: Standard GlideScope | Active comparator | Control: Patients will be intubated using standard practice, a standard GlideScope (Verathon) Receives: Device: Control: Standard GlideScope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Intubation
Duration of Intubation - Mask removal to ETCO2 confirmation
Measured: Day 1
Secondary outcomes (6)
Ease of intubation
Ease of intubation as noted by operator (measured on a 100 mm Visual Analogue Scale)
Measured: Day 1
Incidence of trauma
Incidence of trauma
Measured: Day 1
Number of failures to intubate
Number of failures to intubate
Measured: Day 1
Use of external laryngeal pressure
Use of external laryngeal pressure
Measured: Day 1
Laryngoscopic grade distribution
Laryngoscopic grade distribution according to Cormack and Lehane classification
Measured: Day 1
Sore Throat
Patients will be surveyed with respect to the incidence of post-operative sore throat.
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2011 (estimated)
- Study startJul 2019 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Why it stopped: Device Withdrawn from market
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation, OrotrachealStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- University of Western Ontario, Canada
- Responsible party
- Principal investigator, Timothy Turkstra, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Timothy Turkstra, MD, M. Eng, Principal investigator, UWO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01489605
- Sponsor's protocol ID
- 18477
- Status last verified
- Feb 2019
- First submitted
- 8 Dec 2011
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of GlideScope Groove to Standard GlideScope for Orotracheal Intubation: A Non-inferiority Study
- ClinicalTrials.gov ID
- NCT01489605
- Acronym / sponsor ID
- 18477
- Conditions
- Intubation, Orotracheal
- Keywords
- Orotracheal intubation, videolaryngoscopy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Device Withdrawn from market
- Enrolment
- 0 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- University of Western Ontario, Canada
- Study start
- Jul 2019 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 9 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients presenting for elective surgery requiring orotracheal intubation will be randomized to being intubated with either the GlideScope Groove video-laryngoscope or the standard GlideScope video-laryngoscope.
Detailed description
See above. The primary outcome is time to intubation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GlideScope Groove | Experimental | Device: GlideScope GroovePatients will be intubated using the GlideScope Groove device. (Verathon) |
| Control: Standard GlideScope | Active comparator | Device: Control: Standard GlideScopeControl: Patients will be intubated using standard practice, a standard GlideScope (Verathon) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any adult patient booked for elective surgery requiring orotracheal intubation.
Key exclusion criteria (3 listed)
- Any patient with cervical spine abnormalities.
- Any patients with known or probable difficult airways.
- Any patient requiring rapid sequence induction.
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 |
|---|---|---|
| GlideScope GrooveAlso: VerathonPatients will be intubated using the GlideScope Groove device. (Verathon) | Device | GlideScope Groove |
| Control: Standard GlideScopeAlso: VarathonPatients will be intubated using the standard GlideScope. (Verathon) | Device | Control: Standard GlideScope |
Primary outcome
Duration of Intubation
Time frame: Day 1
Duration of Intubation - Mask removal to ETCO2 confirmation
6 secondary outcomes
Ease of intubation
Time frame: Day 1
Incidence of trauma
Time frame: Day 1
Number of failures to intubate
Time frame: Day 1
Use of external laryngeal pressure
Time frame: Day 1
Laryngoscopic grade distribution
Time frame: Day 1
Sore Throat
Time frame: Day 3
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
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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.
Timothy Turkstra, MD, M. Eng principal investigator
UWO
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GlideScope Groove in people with Intubation, Orotracheal, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites in Canada.
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 3 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: withdrawn, as of the sponsor's last update on 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Duration of Intubation (time frame: Day 1). 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 28 Feb 2019.