HealthyNCT00459797
Comparison of Conventional GlideScope to Single-Use GlideScope Cobalt for Orotracheal Intubation
A study testing Conventional (reusable) Glidescope and Single-use Glidescope videolaryngoscope in people with Healthy, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Patients presenting for elective surgery requiring orotracheal intubation will be randomized to being intubated with either the conventional (reusable) GlideScope videolaryngoscope or the single-use GlideScope videolaryngoscope. The primary outcome is time to intubation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Conventional (reusable) Glidescope and Single-use Glidescope videolaryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2007to Aug 2008
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any patient who is ≥ 18 yrs. coming for elective surgery.
- Endotracheal tube is indicated for the procedure in the opinion of the attending anesthesiologist.
- Any operator who has performed ≥ 10 GlideScope intubations.
Who cannot join
- Any patient in whom the use of the GlideScope is contraindicated in the opinion of the attending anesthesiologist.
- Any patient with cervical spine abnormalities.
- Any patients with known or probable difficult airways (this rare occurrence is unlikely to be evenly distributed between the groups and could skew the data).
- Any patient requiring rapid sequence induction.
Trial locations and contacts
1 site in 1 country.
About this study
Patients presenting for elective surgery requiring orotracheal intubation will be randomized to being intubated with either the conventional (reusable) GlideScope videolaryngoscope or the single-use GlideScope videolaryngoscope. The primary outcome is time to intubation.
- Conditions
- Healthy
- Being tested
- Conventional (reusable) Glidescope, Single-use Glidescope videolaryngoscope
- Keywords
- GlideScope, cobalt, single-use, intubation, airway, Elective surgical patients requiring orotracheal intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional (reusable) GlidescopeDevice
Single-use Glidescope videolaryngoscopeDevice
| Study group | Role | What they receive |
|---|---|---|
| Conventional Glidescope | Active comparator | Not described Receives: Device: Conventional (reusable) Glidescope |
| Single-use Glidescope | Experimental | Not described Receives: Device: Single-use Glidescope videolaryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to intubation (seconds)
Measured: Immediate
Secondary outcomes (6)
Ease of intubation
Measured: after intubation
Number of intubation attempts per group
Measured: after intubation
Incidence of trauma in each group
Measured: after intubation
Number of failures to intubate per group
Measured: after intubation
Use of external laryngeal pressure per group
Measured: after intubation
Laryngoscopic grade distribution in each group
Measured: after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- None (open label)
- Enrolment
- 100 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
- Investigators
- Philip M Jones, MD, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00459797
- Sponsor's protocol ID
- R-07-040
- Other IDs
- 13025
- Status last verified
- Apr 2009
- First submitted
- 12 Apr 2007
- Last updated
- 21 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Jones PM, Turkstra TP, Armstrong KP, Armstrong PM, Harle CC. Comparison of a single-use GlideScope Cobalt videolaryngoscope with a conventional GlideScope for orotracheal intubation. Can J Anaesth. 2010 Jan;57(1):18-23. doi: 10.1007/s12630-009-9204-9. Epub 2009 Oct 31.
PubMed 19882199
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Conventional GlideScope to Single-Use GlideScope Cobalt for Orotracheal Intubation
- ClinicalTrials.gov ID
- NCT00459797
- Acronym / sponsor ID
- R-07-040
- Conditions
- Healthy
- Keywords
- GlideScope, cobalt, single-use, intubation, airway, Elective surgical patients requiring orotracheal intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 13 Apr 2007 (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 conventional (reusable) GlideScope videolaryngoscope or the single-use GlideScope videolaryngoscope. The primary outcome is time to intubation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Glidescope | Active comparator | Device: Conventional (reusable) Glidescope |
| Single-use Glidescope | Experimental | Device: Single-use Glidescope videolaryngoscope |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Any patient who is ≥ 18 yrs. coming for elective surgery.
- Endotracheal tube is indicated for the procedure in the opinion of the attending anesthesiologist.
- Any operator who has performed ≥ 10 GlideScope intubations.
Key exclusion criteria (4 listed)
- Any patient in whom the use of the GlideScope is contraindicated in the opinion of the attending anesthesiologist.
- Any patient with cervical spine abnormalities.
- Any patients with known or probable difficult airways (this rare occurrence is unlikely to be evenly distributed between the groups and could skew the data).
- 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 |
|---|---|---|
| Conventional (reusable) Glidescope | Device | Conventional Glidescope |
| Single-use Glidescope videolaryngoscope | Device | Single-use Glidescope |
Primary outcome
Time to intubation (seconds)
Time frame: Immediate
6 secondary outcomes
Ease of intubation
Time frame: after intubation
Number of intubation attempts per group
Time frame: after intubation
Incidence of trauma in each group
Time frame: after intubation
Number of failures to intubate per group
Time frame: after intubation
Use of external laryngeal pressure per group
Time frame: after intubation
Laryngoscopic grade distribution in each group
Time frame: after intubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2009.
- Derived from this study: PubMed 19882199Jones PM, Turkstra TP, Armstrong KP, Armstrong PM, Harle CC. Comparison of a single-use GlideScope Cobalt videolaryngoscope with a conventional GlideScope for orotracheal intubation. Can J Anaesth. 2010 Jan;57(1):18-23. doi: 10.1007/s12630-009-9204-9. Epub 2009 Oct 31.
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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.
Philip M Jones, MD principal investigator
London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional (reusable) Glidescope and Single-use Glidescope videolaryngoscope in people with Healthy, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site 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 3 inclusion and 4 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 21 Apr 2009. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 to intubation (seconds) (time frame: Immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00459797, which also lists 1 linked publication.
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 21 Apr 2009.