Time it Takes to Successfully Intubate the Patient With the GlideScopeNCT02144207
Optimal Laryngoscopic View to Enable GlideScope-assisted Tracheal Intubation
A study testing Glidescope in people with Time it Takes to Successfully Intubate the Patient With the GlideScope and Time to Intubate Between the Two Views, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
Some surgical procedures require general anesthesia (i.e., the patient is 'asleep'). When under general anesthesia, these patients' airways must be managed to ensure continuous flow of oxygen to the lungs, and in most cases, delivery of anesthetic gases to the lungs. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Time it Takes to Successfully Intubate the Patient With the GlideScope, Time to Intubate Between the Two Views
- What is being tested?
- Glidescope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2014to Dec 2015
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- able to provide informed consent
- scheduled for elective surgery at the QEII Health Sciences Centre
- ASA 1-3
Who cannot join
- age < 18 or > 75 years,
- a condition requiring rapid-sequence induction of anesthesia ,
- need for awake tracheal intubation due to anticipated very difficult airway management;
- pregnancy,
- BMI (Body Mass Index) > 40,
- need for non-standard endotracheal tube,
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- allergy to any study medications,
- known cervical myelopathy, intracranial aneurysm or decreased intracranial compliance,
- Anatomic predictors of difficult GlideScope intubation (previous neck radiation or neck surgery),
- known very difficult direct laryngoscopy,
- inter-incisor mouth opening distance of < 3 cm (Cormack-Lehane Grade 3 or 4 laryngoscopy).
Trial locations and contacts
1 site in 1 country.
About this study
Some surgical procedures require general anesthesia (i.e., the patient is 'asleep'). When under general anesthesia, these patients' airways must be managed to ensure continuous flow of oxygen to the lungs, and in most cases, delivery of anesthetic gases to the lungs. Most often for airway management under general anesthesia, a plastic breathing tube is placed though the voicebox ("larynx") into the windpipe ("trachea"), a process known as "tracheal intubation". To safely intubate, the larynx must first be exposed. In many cases, this is achieved by using a device known as a direct laryngoscope, which is like a curved, lighted tongue depressor. It is used to gently move the tongue out of the way, to expose the larynx. When the larynx is easily seen, passing the breathing tube is usually also easy. Unfortunately, in 2-5% of cases, it is difficult or impossible to view the larynx using the direct laryngoscope. This then creates difficulty with tube passage. A number of options exist to deal with this situation, including, within the last 10 years, a class of device called "video laryngoscopes". These devices use a small video chip located towards the end of the blade, which, by providing transmission of an image of the larynx 'around the corner' to a screen outside the patient, enable a view to be obtained (when no such view could be obtained with direct laryngoscope). With the larynx now indirectly visualized, tube passage can proceed. However, it's not that easy. When using these 'around the corner' videolaryngoscopes, tube passage can be more difficult, as the tube must be guided around a 90 degree bend from the mouth to the trachea, which sits at right angles to the mouth. Less difficulty occurs with tube passage when the direct laryngoscope is used because the blade compresses the tongue out of the way, creating a straight line from teeth to the larynx and windpipe beyond.
The GlideScope is one example of video laryngoscope, and has been in use here at CDHA for 10 years. It has been extensively studied over the ten years, with more than 300 studies appearing in the literature. The investigators know from these studies that it is very effective at delivering a view of the larynx when direct laryngoscopy has failed to do so. However, getting the tube to and through the larynx into the trachea, even with a good view, can be problematic. Furthermore, it is the impression of some clinicians that when a close-up, full view of the larynx is obtained (as is optimal for direct laryngoscopy) with the GlideScope, tube passage appears to be a little more difficult than seems to be the case when only a partial view of the larynx is obtained, from a little further away. The investigators don't know why this may be so, but may relate to one or more of a number of reasons, including (when too close) angling the larynx into an unfavorable angle, or (when further away) more favorably reducing the angle between mouth and larynx and trachea. However, no guidance on this question appears in the peer-reviewed medical literature, and no studies have been done. There is some suggestion in non peer-reviewed internet sites on airway management that a partial view may be better, but again, this has not been scientifically studied or validated one way or another.
Read more
As mentioned, the GlideScope has been in regular use in CDHA for many years. Most often, it is used when difficulty with tracheal intubation is anticipated or has already been encountered in the anesthetized patient, although some airway experts suggest that within the near future, all intubations will occur with some sort of video laryngoscope.
It is important to research the present question as in contemporary practice many anesthesiologists, faced with a patient in whom they are anticipating difficult direct laryngoscopy proceed with putting the patient to sleep, relying on the video laryngoscope to enable them to intubate. With a patient now anesthetized and not breathing, if they then have trouble intubating the patient in spite of getting a view of the larynx, harm could occur to the patient from a failed intubation situation. Furthermore, there are now a number of studies documenting that patient morbidity can increase with multiple intubation attempts.
- Conditions
- Time it Takes to Successfully Intubate the Patient With the GlideScope, Time to Intubate Between the Two Views
- Being tested
- Glidescope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlidescopeDevice
| Study group | Role | What they receive |
|---|---|---|
| Glidescope: Unrestricted View | Active comparator | Unrestricted view of the larynx. Receives: Device: Glidescope |
| Glidescope: Restricted View | Active comparator | Restricted view of the larynx. Receives: Device: Glidescope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to intubate for a deliberately obtaining a restricted (Grade 2) view of the larynx using an indirect videolaryngoscope (GlideScope®)
Does a deliberately restricted view result in a significantly different time to successfully intubate the patient compared to an unrestricted (Grade 1) view?
Measured: At intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2015
- Study completionDec 2015
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 Time it Takes to Successfully Intubate the Patient With the GlideScopeStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam LAw, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02144207
- Sponsor's protocol ID
- CDAH-RS/2014-LAW
- Status last verified
- Jan 2017
- First submitted
- 15 May 2014
- Last updated
- 31 Jan 2017
- Results posted
- No
Publications
Gu Y, Robert J, Kovacs G, Milne AD, Morris I, Hung O, MacQuarrie K, Mackinnon S, Adam Law J. A deliberately restricted laryngeal view with the GlideScope(R) video laryngoscope is associated with faster and easier tracheal intubation when compared with a full glottic view: a randomized clinical trial. Can J Anaesth. 2016 Aug;63(8):928-37. doi: 10.1007/s12630-016-0654-6. Epub 2016 Apr 18.
PubMed 27090535
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Laryngoscopic View to Enable GlideScope-assisted Tracheal Intubation
- ClinicalTrials.gov ID
- NCT02144207
- Acronym / sponsor ID
- CDAH-RS/2014-LAW
- Conditions
- Time it Takes to Successfully Intubate the Patient With the GlideScope, Time to Intubate Between the Two Views
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 May 2014 (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.
Some surgical procedures require general anesthesia (i.e., the patient is 'asleep'). When under general anesthesia, these patients' airways must be managed to ensure continuous flow of oxygen to the lungs, and in most cases, delivery of anesthetic gases to the lungs. Most often for airway management under general anesthesia, a plastic breathing tube is placed though the voicebox ("larynx") into the windpipe ("trachea"), a process known as "tracheal intubation". To safely intubate, the larynx must first be exposed. In many cases, this is achieved by using a device known as a direct laryngoscope, which is like a curved, lighted tongue depressor. It is used to gently move the tongue out of the way, to expose the larynx. When the larynx is easily seen, passing the breathing tube is usually also easy. Unfortunately, in 2-5% of cases, it is difficult or impossible to view the larynx using the direct laryngoscope. This then creates difficulty with tube passage. A number of options exist to deal with this situation, including, within the last 10 years, a class of device called "video laryngoscopes". These devices use a small video chip located towards the end of the blade, which, by providing transmission of an image of the larynx 'around the corner' to a screen outside the patient, enable a view to be obtained (when no such view could be obtained with direct laryngoscope). With the larynx now indirectly visualized, tube passage can proceed. However, it's not that easy. When using these 'around the corner' videolaryngoscopes, tube passage can be more difficult, as the tube must be guided around a 90 degree bend from the mouth to the trachea, which sits at right angles to the mouth. Less difficulty occurs with tube passage when the direct laryngoscope is used because the blade compresses the tongue out of the way, creating a straight line from teeth to the larynx and windpipe beyond.
The GlideScope is one example of video laryngoscope, and has been in use here at CDHA for 10 years. It has been extensively studied over the ten years, with more than 300 studies appearing in the literature. The investigators know from these studies that it is very effective at delivering a view of the larynx when direct laryngoscopy has failed to do so. However, getting the tube to and through the larynx into the trachea, even with a good view, can be problematic. Furthermore, it is the impression of some clinicians that when a close-up, full view of the larynx is obtained (as is optimal for direct laryngoscopy) with the GlideScope, tube passage appears to be a little more difficult than seems to be the case when only a partial view of the larynx is obtained, from a little further away. The investigators don't know why this may be so, but may relate to one or more of a number of reasons, including (when too close) angling the larynx into an unfavorable angle, or (when further away) more favorably reducing the angle between mouth and larynx and trachea. However, no guidance on this question appears in the peer-reviewed medical literature, and no studies have been done. There is some suggestion in non peer-reviewed internet sites on airway management that a partial view may be better, but again, this has not been scientifically studied or validated one way or another.
As mentioned, the GlideScope has been in regular use in CDHA for many years. Most often, it is used when difficulty with tracheal intubation is anticipated or has already been encountered in the anesthetized patient, although some airway experts suggest that within the near future, all intubations will occur with some sort of video laryngoscope.
It is important to research the present question as in contemporary practice many anesthesiologists, faced with a patient in whom they are anticipating difficult direct laryngoscopy proceed with putting the patient to sleep, relying on the video laryngoscope to enable them to intubate. With a patient now anesthetized and not breathing, if they then have trouble intubating the patient in spite of getting a view of the larynx, harm could occur to the patient from a failed intubation situation. Furthermore, there are now a number of studies documenting that patient morbidity can increase with multiple intubation attempts.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glidescope: Unrestricted View | Active comparator | Device: GlidescopeUnrestricted view of the larynx. |
| Glidescope: Restricted View | Active comparator | Device: GlidescopeRestricted view of the larynx. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- able to provide informed consent
- scheduled for elective surgery at the QEII Health Sciences Centre
- ASA 1-3
Key exclusion criteria (11 listed)
- age < 18 or > 75 years,
- a condition requiring rapid-sequence induction of anesthesia ,
- need for awake tracheal intubation due to anticipated very difficult airway management;
- pregnancy,
- BMI (Body Mass Index) > 40,
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 | Device | Glidescope: Restricted View, Glidescope: Unrestricted View |
Primary outcome
Time to intubate for a deliberately obtaining a restricted (Grade 2) view of the larynx using an indirect videolaryngoscope (GlideScope®)
Time frame: At intubation
Does a deliberately restricted view result in a significantly different time to successfully intubate the patient compared to an unrestricted (Grade 1) view?
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 31 Jan 2017.
- Derived from this study: PubMed 27090535Gu Y, Robert J, Kovacs G, Milne AD, Morris I, Hung O, MacQuarrie K, Mackinnon S, Adam Law J. A deliberately restricted laryngeal view with the GlideScope(R) video laryngoscope is associated with faster and easier tracheal intubation when compared with a full glottic view: a randomized clinical trial. Can J Anaesth. 2016 Aug;63(8):928-37. doi: 10.1007/s12630-016-0654-6. Epub 2016 Apr 18.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Time it Takes to Successfully Intubate the Patient With the GlideScope and Time to Intubate Between the Two Views, run by Nova Scotia Health Authority 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 11 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 31 Jan 2017. 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 intubate for a deliberately obtaining a restricted (Grade 2) view of the larynx using an indirect videolaryngoscope (GlideScope®) (time frame: At intubation). 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 NCT02144207, 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 31 Jan 2017.