Endotracheal IntubationNCT00992628
Measurement of Forces Applied Using a Macintosh Direct Laryngoscope Compared to GlideScope Video Laryngoscope
A study testing Macintosh (direct vision) laryngoscope and GlideScope videolaryngoscope (indirect vision) in people with Endotracheal Intubation and Laryngoscopy, run by University Health Network, Toronto at 2 sites in Canada.
Trial summary
Patients undergoing surgery or intensive care management often require a tube to be inserted into the trachea allowing lung ventilation. Usually a laryngoscope is used to allow visualisation of the larynx and facilitate intubation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endotracheal Intubation, Laryngoscopy
- What is being tested?
- Macintosh (direct vision) laryngoscope and GlideScope videolaryngoscope (indirect vision)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesCanada
- Study dates
- Jul 2010to Apr 2011
- 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
- ASA 1-2
- elective surgery
- endotracheal intubation required (with non-depolarising muscle relaxant)
- signed informed consent
Who cannot join
- lack of informed consent
- endotracheal intubation not required
- ASA 3-5
- symptomatic gastro-oesophageal reflux
- rapid sequence intubation
- other method of intubation indicated eg fibreoptic, awake tracheostomy
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- cervical spine instability
- unstable hypertension
- coronary artery disease
- cerebral disease
- COPD/asthma
- oral/pharyngeal/laryngeal carcinoma
- loose teeth/poor dentition
- Macintosh laryngoscope >size 3 required
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Toronto General Hospital, UHN
Toronto, Ontario, M5G 2C4
Toronto General Hospital, University Health Network
Toronto, Ontario, M5G 2C4
About this study
Patients undergoing surgery or intensive care management often require a tube to be inserted into the trachea allowing lung ventilation. Usually a laryngoscope is used to allow visualisation of the larynx and facilitate intubation.
During direct laryngoscopy, the blade of the laryngoscope is inserted into the patient's mouth and the structures pulled upwards out of the line of vision. If visualisation is difficult, users often exert excess force on the tissues to obtain an adequate view. Generally the applied force is evaluated by the patient's stress response such as increased heart rate, blood pressure or plasma cortisol levels. These changes, while important, may be confounded by a variety of patient factors, as well as anaesthesia. An increased force may also be associated with tissue trauma, dental damage, and prolonged attempts.
The investigators' objective is to compare the force exerted on patient's tissues by the Macintosh laryngoscope and GlideScope video-laryngoscope. Video-laryngoscopes may be associated with the application of reduced force to the soft tissues of patients during intubation. While this is a common contention, it has not been proven. The GlideScope has a micro camera in the distal portion of the blade meaning a direct line of vision is not required. An adequate view can therefore be obtained with less displacement of tongue tissue. If the force exerted by the video laryngoscope is less, this would have beneficial implications by reducing stress response, neck movement, and trauma.
- Conditions
- Endotracheal Intubation, Laryngoscopy
- Being tested
- Macintosh (direct vision) laryngoscope, GlideScope videolaryngoscope (indirect vision)
- Keywords
- GlideScope Video Laryngoscope, Macintosh Direct Laryngoscope, Intubation, Applied Forces, Elective surgery where endotracheal intubation required
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macintosh (direct vision) laryngoscopeDevice
Macintosh (direct vision) laryngoscope
GlideScope videolaryngoscope (indirect vision)Device
GlideScope videolaryngoscope (indirect vision)
| Study group | Role | What they receive |
|---|---|---|
| Macintosh (direct vision) laryngoscope | Active comparator | Macintosh (direct vision) laryngoscope Receives: Device: Macintosh (direct vision) laryngoscope |
| GlideScope videolaryngoscope (indirect vision) | Active comparator | GlideScope videolaryngoscope (indirect vision) Receives: Device: GlideScope videolaryngoscope (indirect vision) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forces generated during the intubation process using both laryngoscopes including peak and mean forces.
Measured: 5-15minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2009 (estimated)
- Study startJul 2010
- Primary completionFeb 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endotracheal IntubationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Investigators
- Richard Cooper, MD, Principal investigator, Toronto General Hospital, University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00992628
- Sponsor's protocol ID
- UHN REB 09-0262-B
- Status last verified
- Apr 2011
- First submitted
- 1 May 2009
- Last updated
- 15 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2011. 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
- ClinicalTrials.gov ID
- NCT00992628
- Acronym / sponsor ID
- UHN REB 09-0262-B
- Conditions
- Endotracheal Intubation, Laryngoscopy
- Keywords
- GlideScope Video Laryngoscope, Macintosh Direct Laryngoscope, Intubation, Applied Forces, Elective surgery where endotracheal intubation required
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 9 Oct 2009 (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 undergoing surgery or intensive care management often require a tube to be inserted into the trachea allowing lung ventilation. Usually a laryngoscope is used to allow visualisation of the larynx and facilitate intubation.
During direct laryngoscopy, the blade of the laryngoscope is inserted into the patient's mouth and the structures pulled upwards out of the line of vision. If visualisation is difficult, users often exert excess force on the tissues to obtain an adequate view. Generally the applied force is evaluated by the patient's stress response such as increased heart rate, blood pressure or plasma cortisol levels. These changes, while important, may be confounded by a variety of patient factors, as well as anaesthesia. An increased force may also be associated with tissue trauma, dental damage, and prolonged attempts.
The investigators' objective is to compare the force exerted on patient's tissues by the Macintosh laryngoscope and GlideScope video-laryngoscope. Video-laryngoscopes may be associated with the application of reduced force to the soft tissues of patients during intubation. While this is a common contention, it has not been proven. The GlideScope has a micro camera in the distal portion of the blade meaning a direct line of vision is not required. An adequate view can therefore be obtained with less displacement of tongue tissue. If the force exerted by the video laryngoscope is less, this would have beneficial implications by reducing stress response, neck movement, and trauma.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Macintosh (direct vision) laryngoscope | Active comparator | Device: Macintosh (direct vision) laryngoscopeMacintosh (direct vision) laryngoscope |
| GlideScope videolaryngoscope (indirect vision) | Active comparator | Device: GlideScope videolaryngoscope (indirect vision)GlideScope videolaryngoscope (indirect vision) |
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
- ASA 1-2
- elective surgery
- endotracheal intubation required (with non-depolarising muscle relaxant)
- signed informed consent
Key exclusion criteria (14 listed)
- lack of informed consent
- endotracheal intubation not required
- ASA 3-5
- symptomatic gastro-oesophageal reflux
- 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 |
|---|---|---|
| Macintosh (direct vision) laryngoscopeMacintosh (direct vision) laryngoscope | Device | Macintosh (direct vision) laryngoscope |
| GlideScope videolaryngoscope (indirect vision)GlideScope videolaryngoscope (indirect vision) | Device | GlideScope videolaryngoscope (indirect vision) |
Primary outcome
Forces generated during the intubation process using both laryngoscopes including peak and mean forces.
Time frame: 5-15minutes
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 15 Apr 2011.
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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.
Richard Cooper, MD principal investigator
Toronto General Hospital, University Health Network
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Macintosh (direct vision) laryngoscope and GlideScope videolaryngoscope (indirect vision) in people with Endotracheal Intubation and Laryngoscopy, run by University Health Network, Toronto at 2 sites 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 14 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 15 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Forces generated during the intubation process using both laryngoscopes including peak and mean forces. (time frame: 5-15minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2011.