Tracheal IntubationNCT01793727
Infant Glidescope® Learning Curve
A study testing Glidescope videolaryngoscope in people with Tracheal Intubation, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
A prospective trial evaluating the learning curve associated with the use of a videolaryngoscope compared to conventional direct laryngoscopy in infants intubated by anesthesiology residents. Hypothesis: The learning curves of both instruments are equivalent. Read more about this study
- Who is it for?
- Ages Up to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Tracheal Intubation
- What is being tested?
- Glidescope videolaryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 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 Up to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- infants under 10 kg undergoing general anesthesia and requiring tracheal intubation
Who cannot join
- Difficult airway, severe cardiorespiratory disease, emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Learning Curve of the Infant Glidescope® Cobalt Video Laryngoscope in Anesthesiology Residents
A prospective trial evaluating the learning curve associated with the use of a videolaryngoscope compared to conventional direct laryngoscopy in infants intubated by anesthesiology residents. Hypothesis: The learning curves of both instruments are equivalent.
- Conditions
- Tracheal Intubation
- Being tested
- Glidescope videolaryngoscope
- Keywords
- infants, general anesthesia, tracheal intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glidescope videolaryngoscopeDevice
| Study group | Role | What they receive |
|---|---|---|
| Glidescope intubation | Experimental | Comparison of direct laryngoscopy and Glidescope videolaryngoscopy Receives: Device: Glidescope videolaryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to optimum visualization of the vocal cords
Measured: Under 2 minutes
Secondary outcomes (1)
Time to tracheal intubation
Measured: Under 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 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.
- Other trials for Tracheal IntubationStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cengiz Karsli, The Hospital for Sick Children
- Investigators
- Cengiz Karsli, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01793727
- Sponsor's protocol ID
- 1000023363
- Status last verified
- Apr 2018
- First submitted
- 12 Feb 2013
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning Curve of the Infant Glidescope® Cobalt Video Laryngoscope in Anesthesiology Residents
- ClinicalTrials.gov ID
- NCT01793727
- Acronym / sponsor ID
- 1000023363
- Conditions
- Tracheal Intubation
- Keywords
- infants, general anesthesia, tracheal intubation
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 15 Feb 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.
A prospective trial evaluating the learning curve associated with the use of a videolaryngoscope compared to conventional direct laryngoscopy in infants intubated by anesthesiology residents. Hypothesis: The learning curves of both instruments are equivalent.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glidescope intubation | Experimental | Device: Glidescope videolaryngoscopeComparison of direct laryngoscopy and Glidescope videolaryngoscopy |
Who may qualify
- Ages
- Up to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- infants under 10 kg undergoing general anesthesia and requiring tracheal intubation
Key exclusion criteria (1 listed)
- Difficult airway, severe cardiorespiratory disease, emergency surgery
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 videolaryngoscope | Device | Glidescope intubation |
Primary outcome
Time to optimum visualization of the vocal cords
Time frame: Under 2 minutes
1 secondary outcome
Time to tracheal intubation
Time frame: Under 2 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
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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.
Cengiz Karsli, MD principal investigator
The Hospital for Sick Children
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 videolaryngoscope in people with Tracheal Intubation, run by The Hospital for Sick Children 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 18 Apr 2018. 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 was withdrawn before enrolling participants, so there are no results.
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 optimum visualization of the vocal cords (time frame: Under 2 minutes). 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 18 Apr 2018.