- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02787629
Comparison of Simultaneous Endotracheal Tube Insertion With GlideScope Use
February 27, 2019 updated by: Lawson Health Research Institute
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A 4V2
- St. Joseph's Health Care
-
London, Ontario, Canada, N6A5A5
- London Health Sciences Center University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
1) Adult patient booked for elective surgery requiring orotracheal intubation
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Simultaneous
Simultaneous Intubation with GlideScope and ETT inserted simultaneously
|
Intubation with GlideScope and ETT inserted simultaneously
|
|
Active Comparator: Control Standard
Standard Intubation with GlideScope inserted first and ETT inserted after the GlideScope view is obtained
|
Intubation with GlideScope inserted first and ETT insertion after the GlideScope view is obtained
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Duration of Intubation
Time Frame: During the intubation
|
Duration of Intubation from mask removal to confirmation of ETCO2
|
During the intubation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ease of Intubation
Time Frame: Within 5 minutes of the completion of the intubation
|
100 mm visual analog scale
|
Within 5 minutes of the completion of the intubation
|
|
Number of intubation attempts
Time Frame: Within 5 minutes of the completion of the intubation
|
Number of intubation attempts
|
Within 5 minutes of the completion of the intubation
|
|
Failure to intubate
Time Frame: Within 5 minutes of the completion of the intubation
|
Failure to intubate
|
Within 5 minutes of the completion of the intubation
|
|
Laryngoscopic Grade
Time Frame: Within 5 minutes of the completion of the intubation
|
Cormack & Lehane grade
|
Within 5 minutes of the completion of the intubation
|
|
Oropharyngeal Trauma
Time Frame: Within 5 minutes of the completion of the intubation
|
Blind suction of the oropharynx immediately post intubation
|
Within 5 minutes of the completion of the intubation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Timothy Turkstra, University of Western Ontario, Canada
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2016
Primary Completion (Actual)
June 30, 2018
Study Completion (Actual)
June 30, 2018
Study Registration Dates
First Submitted
May 25, 2016
First Submitted That Met QC Criteria
May 27, 2016
First Posted (Estimate)
June 1, 2016
Study Record Updates
Last Update Posted (Actual)
March 1, 2019
Last Update Submitted That Met QC Criteria
February 27, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 107322
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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