Endotracheal IntubationNCT01564082
Comparison of Early Endotracheal Tube Insertion With GlideScope Use
A study testing ETT First (GlideScope) in people with Endotracheal Intubation, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites in Canada.
Trial summary
Patients presenting for elective surgery will be randomized to having the breathing tube inserted partly into the throat prior to GlideScope insertion, or having it inserted fully after GlideScope insertion. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Endotracheal Intubation
- What is being tested?
- ETT First (GlideScope)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesCanada
- Study dates
- Apr 2012to Mar 2013
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any adult patient booked for elective surgery requiring orotracheal intubation.
- Any operator who has performed ≥ 20 GlideScope intubations.
Who cannot join
- Any patient in whom the use of the GlideScope is contraindicated in the opinion of the attending anesthesiologist.
- Any patient with cervical spine abnormalities.
- Any patients with known or probable difficult airways.
- Any patient requiring rapid sequence induction.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
St. Joseph's Health Care
London, Ontario, N6A 4V2
London Health Sciences Center
London, Ontario, N6A5A5
About this study
Patients presenting for elective surgery will be randomized to having the breathing tube inserted partly into the throat prior to GlideScope insertion, or having it inserted fully after GlideScope insertion.
Read the detailed description
Patients presenting for elective surgery requiring orotracheal intubation will be randomized to having the Early Endotracheal Tube (ETT) inserted into the pharynx prior to GlideScope insertion and then having the ETT advanced under GlideScope guidance into the trachea, or, being intubated in the standard fashion with the GlideScope being inserted first and having the ETT then advanced via the pharynx into the trachea. The primary outcome is time to intubation.
- Conditions
- Endotracheal Intubation
- Being tested
- ETT First (GlideScope)
- Keywords
- endotracheal intubation, GlideScope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETT First (GlideScope)Device
Patients will have the endotracheal tube (ETT) introduced into the pharynx under direct vision prior to GlideScope insertion. The ETT will then be advanced under GlideScope guidance into the trachea.
| Study group | Role | What they receive |
|---|---|---|
| ETT first | Experimental | Patients will have the endotracheal tube (ETT) introduced into the pharynx prior to GlideScope insertion, and then advanced under GlideScope guidance into the trachea. Receives: Device: ETT First (GlideScope) |
| Control Group | No intervention | Patients will have the GlideScope introduced into the pharynx. The endotracheal tube (ETT) will then be advanced under direct vision into the mouth/pharynx. The ETT will then be advanced into the trachea under GlideScope guidance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Intubation
Duration of intubation of the patient
Measured: Day 1
Secondary outcomes (4)
Ease of intubation
Ease of intubation, measured on a Visual analog scale
Measured: Day 1
Number of intubation attempts
Number of intubation attempts
Measured: Day 1
Use of external laryngeal pressure
Use of external laryngeal pressure
Measured: Day 1
Sore throat
Post operative sore throat, as rated by the patient.
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionMar 2013
- Study completionMar 2013
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 London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Turkstra, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Timothy P Turkstra, MD, M. Eng., Principal investigator, LHRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01564082
- Sponsor's protocol ID
- 18855
- Status last verified
- Apr 2015
- First submitted
- 6 Mar 2012
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Early Endotracheal Tube Insertion With GlideScope Use
- ClinicalTrials.gov ID
- NCT01564082
- Acronym / sponsor ID
- 18855
- Conditions
- Endotracheal Intubation
- Keywords
- endotracheal intubation, GlideScope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 27 Mar 2012 (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 presenting for elective surgery will be randomized to having the breathing tube inserted partly into the throat prior to GlideScope insertion, or having it inserted fully after GlideScope insertion.
Detailed description
Patients presenting for elective surgery requiring orotracheal intubation will be randomized to having the Early Endotracheal Tube (ETT) inserted into the pharynx prior to GlideScope insertion and then having the ETT advanced under GlideScope guidance into the trachea, or, being intubated in the standard fashion with the GlideScope being inserted first and having the ETT then advanced via the pharynx into the trachea. The primary outcome is time to intubation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ETT first | Experimental | Device: ETT First (GlideScope)Patients will have the endotracheal tube (ETT) introduced into the pharynx prior to GlideScope insertion, and then advanced under GlideScope guidance into the trachea. |
| Control Group | No intervention | –Patients will have the GlideScope introduced into the pharynx. The endotracheal tube (ETT) will then be advanced under direct vision into the mouth/pharynx. The ETT will then be advanced into the trachea under GlideScope guidance. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any adult patient booked for elective surgery requiring orotracheal intubation.
- Any operator who has performed ≥ 20 GlideScope intubations.
Key exclusion criteria (4 listed)
- Any patient in whom the use of the GlideScope is contraindicated in the opinion of the attending anesthesiologist.
- Any patient with cervical spine abnormalities.
- Any patients with known or probable difficult airways.
- Any patient requiring rapid sequence induction.
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 |
|---|---|---|
| ETT First (GlideScope)Patients will have the endotracheal tube (ETT) introduced into the pharynx under direct vision prior to GlideScope insertion. The ETT will then be advanced under GlideScope guidance into the trachea. | Device | ETT first |
Primary outcome
Time to Intubation
Time frame: Day 1
Duration of intubation of the patient
4 secondary outcomes
Ease of intubation
Time frame: Day 1
Number of intubation attempts
Time frame: Day 1
Use of external laryngeal pressure
Time frame: Day 1
Sore throat
Time frame: Day 3
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 10 Apr 2015.
Related trials for Endotracheal Intubation
Not yet recruitingObservational study
AI-assisted Tracheal Intubation in Children
Intubation
Not yet recruiting
AI Smart Glasses Feedback for Intubation Training in Medical Students
Intubation, Intratracheal, Medical Education
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Recruiting
Effect of a Brief Educational Intervention on Endotracheal Tube Cuff Pressure
Intubation, Endotracheal Tube Cuff Pressure
Recruiting
Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation
Endobronchial Intubation, Double Lumen Tube Intubation
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.
Timothy P Turkstra, MD, M. Eng. principal investigator
LHRI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ETT First (GlideScope) in people with Endotracheal Intubation, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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 2 inclusion and 4 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 10 Apr 2015. 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?
Time to Intubation (time frame: Day 1). 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 10 Apr 2015.