Moderately Difficult to IntubateNCT01814176
Measurement of Forces Applied Using a Macintosh Direct Laryngoscope Compared to GlideScope Video Laryngoscope
A study testing Intubation with GlideScope Video Laryngoscope or Macintosh Direct Laryngoscope in people with Moderately Difficult to Intubate, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
During Anesthesia many patients require that a breathing be inserted into their windpipe. This is usually achieved using a direct laryngoscope, consisting of a retraction blade with a light near its end. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderately Difficult to Intubate
- What is being tested?
- Intubation with GlideScope Video Laryngoscope or Macintosh Direct Laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2011to Jun 2012
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18years
- elective surgery
- single lumen endotracheal intubation required
- signed informed consent
- one risk factor for a difficult laryngoscopy ( Mallampati score >3, inter-incisor gap < 3.5cm, thyromental distance < 6.5cm, sternomental distance < 12.5cm, reduced neck extension and flexion)
Who cannot join
- lack of patient consent
- anesthesiologist declines to consent
- contraindication to neuromuscular blockade
- ASA 4
- rapid sequence intubation
- previous failed intubation
Show all 13Show fewer
- other method of intubation indicated eg fiberoptic intubation, awake tracheostomy
- symptomatic gastro-esophageal reflux
- cervical spine instability
- unstable hypertension and symptomatic coronary artery disease
- cerebrovascular disease or raised intracranial pressure
- oral/pharyngeal/laryngeal carcinoma
- loose teeth/poor dentition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measurement of Forces Applied Using a Macintosh Direct Laryngoscope Compared to GlideScope Video Laryngoscope in Patients With at Least One Difficult Intubation Risk Factor
During Anesthesia many patients require that a breathing be inserted into their windpipe. This is usually achieved using a direct laryngoscope, consisting of a retraction blade with a light near its end. When achieving a direct line-of-sight to the windpipe is difficult, more force is often applied, resulting in greater patient stress. A GlideScope video laryngoscope uses a camera and light source to see the windpipe. This enables the user to see objects that may not be in the direct line-of-sight. This likely results in less force being required, reducing patient stress. Because such stresses are often confounded by patient variables, we are comparing the forces required by the direct and video laryngoscopes on patients with at least one risk factor for difficulty, by directly measuring these with special sensors attached to the laryngoscope blades.
- Conditions
- Moderately Difficult to Intubate
- Being tested
- Intubation with GlideScope Video Laryngoscope or Macintosh Direct Laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intubation with GlideScope Video Laryngoscope or Macintosh Direct LaryngoscopeDevice
| Study group | Role | What they receive |
|---|---|---|
| Macintosh Direct Laryngoscope | Active comparator | 2 main forces - a 'lifting' force to elevate the structures not in the line of sight and a force exerted by the user's wrist to counterbalance the torque effect of the tongue tissues on the blade Receives: Device: Intubation with GlideScope Video Laryngoscope or Macintosh Direct Laryngoscope |
| GlideScope Video Laryngoscope | Active comparator | The GlideScope has a 60º angulation anteriorly at the distal portion of the blade, allowing an anterior view of the larynx. Receives: Device: Intubation with GlideScope Video Laryngoscope or Macintosh Direct Laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak forces during intubation
Peak forces generated during the laryngoscopy and intubation process using both laryngoscopes.
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2013 (estimated)
- Study startJul 2011
- Primary completionJun 2012
- Study completionJun 2012
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 Moderately Difficult to IntubateStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01814176
- Sponsor's protocol ID
- 11-0229-B
- Status last verified
- Mar 2013
- First submitted
- 15 Mar 2013
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Cordovani D, Russell T, Wee W, Suen A, Cooper RM. Measurement of forces applied using a Macintosh direct laryngoscope compared with a Glidescope video laryngoscope in patients with predictors of difficult laryngoscopy: A randomised controlled trial. Eur J Anaesthesiol. 2019 Mar;36(3):221-226. doi: 10.1097/EJA.0000000000000901.
PubMed 30308524
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Forces Applied Using a Macintosh Direct Laryngoscope Compared to GlideScope Video Laryngoscope in Patients With at Least One Difficult Intubation Risk Factor
- ClinicalTrials.gov ID
- NCT01814176
- Acronym / sponsor ID
- 11-0229-B
- Conditions
- Moderately Difficult to Intubate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 19 Mar 2013 (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.
During Anesthesia many patients require that a breathing be inserted into their windpipe. This is usually achieved using a direct laryngoscope, consisting of a retraction blade with a light near its end. When achieving a direct line-of-sight to the windpipe is difficult, more force is often applied, resulting in greater patient stress. A GlideScope video laryngoscope uses a camera and light source to see the windpipe. This enables the user to see objects that may not be in the direct line-of-sight. This likely results in less force being required, reducing patient stress. Because such stresses are often confounded by patient variables, we are comparing the forces required by the direct and video laryngoscopes on patients with at least one risk factor for difficulty, by directly measuring these with special sensors attached to the laryngoscope blades.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Macintosh Direct Laryngoscope | Active comparator | Device: Intubation with GlideScope Video Laryngoscope or Macintosh Direct Laryngoscope2 main forces - a 'lifting' force to elevate the structures not in the line of sight and a force exerted by the user's wrist to counterbalance the torque effect of the tongue tissues on the blade |
| GlideScope Video Laryngoscope | Active comparator | Device: Intubation with GlideScope Video Laryngoscope or Macintosh Direct LaryngoscopeThe GlideScope has a 60º angulation anteriorly at the distal portion of the blade, allowing an anterior view of the larynx. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age > 18years
- elective surgery
- single lumen endotracheal intubation required
- signed informed consent
- one risk factor for a difficult laryngoscopy ( Mallampati score >3, inter-incisor gap < 3.5cm, thyromental distance < 6.5cm, sternomental distance < 12.5cm, reduced neck extension and flexion)
Key exclusion criteria (13 listed)
- lack of patient consent
- anesthesiologist declines to consent
- contraindication to neuromuscular blockade
- ASA 4
- rapid sequence intubation
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 |
|---|---|---|
| Intubation with GlideScope Video Laryngoscope or Macintosh Direct Laryngoscope | Device | GlideScope Video Laryngoscope, Macintosh Direct Laryngoscope |
Primary outcome
Peak forces during intubation
Time frame: Intraoperatively
Peak forces generated during the laryngoscopy and intubation process using both laryngoscopes.
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 7 Dec 2016.
- Derived from this study: PubMed 30308524Cordovani D, Russell T, Wee W, Suen A, Cooper RM. Measurement of forces applied using a Macintosh direct laryngoscope compared with a Glidescope video laryngoscope in patients with predictors of difficult laryngoscopy: A randomised controlled trial. Eur J Anaesthesiol. 2019 Mar;36(3):221-226. doi: 10.1097/EJA.0000000000000901.
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 Intubation with GlideScope Video Laryngoscope or Macintosh Direct Laryngoscope in people with Moderately Difficult to Intubate, run by University Health Network, Toronto 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 5 inclusion and 13 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 7 Dec 2016. 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?
Peak forces during intubation (time frame: Intraoperatively). 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 NCT01814176, 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 7 Dec 2016.