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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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,
Show all 11Show fewer
  • 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.

Canada1 site
  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 2Y9

Other trials in Canada

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.

Being tested
Glidescope

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GlidescopeDevice

Study groups in NCT02144207
Study groupRoleWhat they receive
Glidescope: Unrestricted ViewActive comparatorUnrestricted view of the larynx.
Receives: Device: Glidescope
Glidescope: Restricted ViewActive comparatorRestricted view of the larynx.
Receives: Device: Glidescope

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted21 May 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionJun 2015
  4. Study completionDec 2015

Resources

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)
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

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.

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