AirwayNCT00884754
Comparison of GlideScope-Specific Rigid Stylet to Standard Malleable Stylet for GlideScope Intubation by Novice Operators
A study testing GlideScope rigid stylet in people with Airway, 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 tracheal intubation will be randomized to one of two different endotracheal tube (ETT) stylets. The intubation will be done with a GlideScope videolaryngoscope by a novice operator. The primary outcome is time to intubation. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Airway
- What is being tested?
- GlideScope rigid stylet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2009to Nov 2009
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- any adult patient scheduled for elective surgery.
- ETT 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.
- Patient with known 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 tracheal intubation will be randomized to one of two different endotracheal tube (ETT) stylets. The intubation will be done with a GlideScope videolaryngoscope by a novice operator. The primary outcome is time to intubation.
- Conditions
- Airway
- Being tested
- GlideScope rigid stylet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlideScope rigid styletDevice
Patients will be intubated either with a rigid stylet meant to be used with the GlideScope, or with a standard malleable stylet used with other modalities of intubation.
| Study group | Role | What they receive |
|---|---|---|
| rigid GlideScope Specific Stylet | Experimental | Not described Receives: Device: GlideScope rigid stylet |
| 90º curvature, malleable stylet | Active comparator | Not described Receives: Device: GlideScope rigid stylet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Intubation (Seconds)
Measured: 30-150 seconds (anticipated)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionNov 2009
- Study completionNov 2009
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AirwayStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 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, FRCPC, Principal investigator, LHSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00884754
- Sponsor's protocol ID
- R-08-594
- Other IDs
- 15520
- Status last verified
- Dec 2010
- First submitted
- 20 Apr 2009
- Last updated
- 11 Jan 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Jones PM, Loh FL, Youssef HN, Turkstra TP. A randomized comparison of the GlideRite((R)) Rigid Stylet to a malleable stylet for orotracheal intubation by novices using the GlideScope((R)). Can J Anaesth. 2011 Mar;58(3):256-61. doi: 10.1007/s12630-010-9440-z. Epub 2010 Dec 17.
PubMed 21165728
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of GlideScope-Specific Rigid Stylet to Standard Malleable Stylet for GlideScope Intubation by Novice Operators
- ClinicalTrials.gov ID
- NCT00884754
- Acronym / sponsor ID
- R-08-594
- Conditions
- Airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 21 Apr 2009 (estimated)
- Results
- Posted 11 Jan 2011
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 tracheal intubation will be randomized to one of two different endotracheal tube (ETT) stylets. The intubation will be done with a GlideScope videolaryngoscope by a novice operator. The primary outcome is time to intubation.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rigid GlideScope Specific Stylet | Experimental | Device: GlideScope rigid stylet |
| 90º curvature, malleable stylet | Active comparator | Device: GlideScope rigid stylet |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- any adult patient scheduled for elective surgery.
- ETT 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.
- Patient with known 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 |
|---|---|---|
| GlideScope rigid styletPatients will be intubated either with a rigid stylet meant to be used with the GlideScope, or with a standard malleable stylet used with other modalities of intubation. | Device | 90º curvature, malleable stylet, rigid GlideScope Specific Stylet |
Primary outcome
Time to Intubation (Seconds)
Time frame: 30-150 seconds (anticipated)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21165728Jones PM, Loh FL, Youssef HN, Turkstra TP. A randomized comparison of the GlideRite((R)) Rigid Stylet to a malleable stylet for orotracheal intubation by novices using the GlideScope((R)). Can J Anaesth. 2011 Mar;58(3):256-61. doi: 10.1007/s12630-010-9440-z. Epub 2010 Dec 17.
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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, FRCPC principal investigator
LHSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GlideScope rigid stylet in people with Airway, 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 11 Jan 2011. 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?
Yes. Results are posted in the registry (first posted 11 Jan 2011). 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 to Intubation (Seconds) (time frame: 30-150 seconds (anticipated)). 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 NCT00884754, 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 11 Jan 2011.