IntubationNCT02787629
Comparison of Simultaneous Endotracheal Tube Insertion With GlideScope Use
A study testing Simultaneous Intubation and Standard Intubation in people with Intubation and Videolaryngoscopy, 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 requiring orotracheal intubation will be randomized to having the ETT inserted into the pharynx simultaneous to GlideScope insertion and then having the ETT advanced under GlideScope guidance into the trachea, or, being intubated in the more common fashion with the GlideScope… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intubation, Videolaryngoscopy
- What is being tested?
- Simultaneous Intubation and Standard Intubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Oct 2016to 30 Jun 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Adult patient booked for elective surgery requiring orotracheal intubation
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 University Hospital
London, Ontario, N6A5A5
About this study
Official title: Comparison of Simultaneous Endotracheal Tube Insertion With GlideScope Use: a Pilot Study
Patients presenting for elective surgery requiring orotracheal intubation will be randomized to having the ETT inserted into the pharynx simultaneous to GlideScope insertion and then having the ETT advanced under GlideScope guidance into the trachea, or, being intubated in the more common fashion with the GlideScope being inserted first and having the ETT then advanced via the pharynx into the trachea.
Read the detailed description
Patients presenting for elective surgery requiring orotracheal intubation will be randomized to having the ETT inserted into the pharynx simultaneous to GlideScope insertion and then having the ETT advanced under GlideScope guidance into the trachea, or, being intubated in the more common 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. Secondary outcomes include: 1) Ease of intubation as noted by operator (measured on a 10-cm Visual Analogue Scale) 2) Number of intubation attempts 3) Number of failures to intubate 4) Use of external laryngeal pressure 5) Laryngoscopic grade distribution
- Conditions
- Intubation, Videolaryngoscopy
- Being tested
- Simultaneous Intubation, Standard Intubation
- Keywords
- D007440
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultaneous IntubationProcedure or surgery
Intubation with GlideScope and ETT inserted simultaneously
Standard IntubationProcedure or surgery
Intubation with GlideScope inserted first and ETT insertion after the GlideScope view is obtained
| Study group | Role | What they receive |
|---|---|---|
| Simultaneous | Experimental | Simultaneous Intubation with GlideScope and ETT inserted simultaneously Receives: Procedure: Simultaneous Intubation |
| Control Standard | Active comparator | Standard Intubation with GlideScope inserted first and ETT inserted after the GlideScope view is obtained Receives: Procedure: Standard Intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Intubation
Duration of Intubation from mask removal to confirmation of ETCO2
Measured: During the intubation
Secondary outcomes (5)
Ease of Intubation
100 mm visual analog scale
Measured: Within 5 minutes of the completion of the intubation
Number of intubation attempts
Number of intubation attempts
Measured: Within 5 minutes of the completion of the intubation
Failure to intubate
Failure to intubate
Measured: Within 5 minutes of the completion of the intubation
Laryngoscopic Grade
Cormack \& Lehane grade
Measured: Within 5 minutes of the completion of the intubation
Oropharyngeal Trauma
Blind suction of the oropharynx immediately post intubation
Measured: Within 5 minutes of the completion of the intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study start1 Oct 2016
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
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 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 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
- Sponsor
- Investigators
- Timothy Turkstra, Principal investigator, University of Western Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02787629
- Sponsor's protocol ID
- 107322
- Status last verified
- Feb 2019
- First submitted
- 25 May 2016
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Turkstra TP, Turkstra DC, Pavlosky AW, Jones PM. Simultaneous en bloc endotracheal tube insertion with GlideScope(R) Titanium video laryngoscope use: a randomized-controlled trial. Can J Anaesth. 2020 Nov;67(11):1515-1523. doi: 10.1007/s12630-020-01778-2. Epub 2020 Aug 19.
PubMed 32815101
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Simultaneous Endotracheal Tube Insertion With GlideScope Use: a Pilot Study
- ClinicalTrials.gov ID
- NCT02787629
- Acronym / sponsor ID
- 107322
- Conditions
- Intubation, Videolaryngoscopy
- Keywords
- D007440
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 1 Jun 2016 (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 requiring orotracheal intubation will be randomized to having the ETT inserted into the pharynx simultaneous to GlideScope insertion and then having the ETT advanced under GlideScope guidance into the trachea, or, being intubated in the more common fashion with the GlideScope being inserted first and having the ETT then advanced via the pharynx into the trachea.
Detailed description
Patients presenting for elective surgery requiring orotracheal intubation will be randomized to having the ETT inserted into the pharynx simultaneous to GlideScope insertion and then having the ETT advanced under GlideScope guidance into the trachea, or, being intubated in the more common 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. Secondary outcomes include: 1) Ease of intubation as noted by operator (measured on a 10-cm Visual Analogue Scale) 2) Number of intubation attempts 3) Number of failures to intubate 4) Use of external laryngeal pressure 5) Laryngoscopic grade distribution
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simultaneous | Experimental | Procedure: Simultaneous IntubationSimultaneous Intubation with GlideScope and ETT inserted simultaneously |
| Control Standard | Active comparator | Procedure: Standard IntubationStandard Intubation with GlideScope inserted first and ETT inserted after the GlideScope view is obtained |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Adult patient booked for elective surgery requiring orotracheal intubation
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 |
|---|---|---|
| Simultaneous IntubationIntubation with GlideScope and ETT inserted simultaneously | Procedure or surgery | Simultaneous |
| Standard IntubationIntubation with GlideScope inserted first and ETT insertion after the GlideScope view is obtained | Procedure or surgery | Control Standard |
Primary outcome
Duration of Intubation
Time frame: During the intubation
Duration of Intubation from mask removal to confirmation of ETCO2
5 secondary outcomes
Ease of Intubation
Time frame: Within 5 minutes of the completion of the intubation
Number of intubation attempts
Time frame: Within 5 minutes of the completion of the intubation
Failure to intubate
Time frame: Within 5 minutes of the completion of the intubation
Laryngoscopic Grade
Time frame: Within 5 minutes of the completion of the intubation
Oropharyngeal Trauma
Time frame: Within 5 minutes of the completion of the intubation
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 1 Mar 2019.
- Derived from this study: PubMed 32815101Turkstra TP, Turkstra DC, Pavlosky AW, Jones PM. Simultaneous en bloc endotracheal tube insertion with GlideScope(R) Titanium video laryngoscope use: a randomized-controlled trial. Can J Anaesth. 2020 Nov;67(11):1515-1523. doi: 10.1007/s12630-020-01778-2. Epub 2020 Aug 19.
- Individual participant dataSharing planned: No
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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.
Timothy Turkstra principal investigator
University of Western Ontario, Canada
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simultaneous Intubation and Standard Intubation in people with Intubation and Videolaryngoscopy, 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 1 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 1 Mar 2019. 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?
Duration of Intubation (time frame: During the 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 NCT02787629, 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 1 Mar 2019.