- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01215422
Success of Pediatric Anesthesiologists in Learning to Use Videolaryngoscopes
October 5, 2012 updated by: Joan Robinson, University of Alberta
Anesthesiologists Learning to Use Videolaryngoscopes in Children
There are two new instruments on the market that anesthesiologists use when putting a breathing tube into the lungs of patients.
The purpose of this study is to see how easily anesthesiologists can learn to use them in children.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Each anesthesiologist performed 20 timed baseline intubations.
They were then randomized to perform 20 timed intubations with one of the two new videolaryngoscopes followed by 20 with the other new videolaryngoscope.
The goal was to see how quickly they could become proficient.
Study Type
Observational
Enrollment (Actual)
646
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
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G 2J3
- Stollery Children's 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
No older than 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children being intubated for surgery
Description
Inclusion Criteria for Children Population:
- Children requiring intubation for elective or non-elective surgery
Exclusion Criteria:
- Children with raised intracranial pressure
- Children with potential cervical spine injuries
- Children at risk for regurgitation because of a full stomach
- Children who were anticipated to have a difficult airway based on their physical appearance or previous experience were excluded.
Inclusion Criteria for Anesthesiologist Population:
*Anesthesiologists who care for children at Stollery Children's Hospital
Exclusion Criteria for Anesthesiologist Population:
*None
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
children intubated with Glidescope
|
timed intubation
|
children intubated with DCI
|
timed intubation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Success in Learning to Use a Videolaryngoscope(VLS)
Time Frame: Up to 5 minutes per intubation
|
Anesthesiologists were to perform 20 intubations with each videolaryngoscopes.
#1-10 were for practice.
"Rapid Success" was no failed intubation attempts on #11-20 and a median time-to-intubation no more than 50% longer than their baseline median time-to-intubation on #11-15 .
"Delayed Success" was achieving these same parameters on #16-20 if they were not achieved on #11-15.
Operators who did not achieve either goal were labeled as having "No Success".
|
Up to 5 minutes per intubation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cormack & Lehane Score
Time Frame: reported during intubation (up to 5 minutes)
|
This Outcome was designed to determine if the view of the airway as determined by the Cormack & Lehane grading system is improved by use of the GlideScope (GS) video laryngoscope and/or the Karl Storz Direct Coupled Interface (DCI) (KS) video laryngoscope as this would be a surrogate marker for utility in a difficult airway.
Score is reported as a whole number from I to IV with I being an easy intubation and IV being one where the larynx cannot be visualized at all.
|
reported during intubation (up to 5 minutes)
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Time to Intubation, Analyzed by Order of Laryngoscopes Used
Time Frame: 4 years
|
To determine if the learning curve was altered by the order in which the two new laryngoscopes were learned by the anesthesiologist,mean and median times on intubations #16-20 were compared for the two videolaryngoscopes.
|
4 years
|
Time to Intubation, Stratified by Weight of Patients
Time Frame: 4 years
|
To compare the time-to-intubation for these laryngoscopes in children of different weights.
|
4 years
|
Mean Years Since Completion of Anesthesiology Residency
Time Frame: Baseline (assessed as of 2008)
|
To investigate whether there was a correlation between the years since completion of anesthesiology residency to the mid-point of study (2008)and median time-to-intubation for all first attempt intubations for the study.
Years since completion of anesthesiology residency reported in the data table, correlation reported in the statistical analysis below
|
Baseline (assessed as of 2008)
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Number of Intubation Attempts to Reach "Best Obtainable Time to Intubation"
Time Frame: less than 5 minutes per intubation
|
For each anesthesiologist, the median time-to-intubation for patients #1-5, #6-10, #11-15, and #16-20 was determined.
The anesthesiologist was considered to have reached "Best Obtainable Time (BOT) to Intubation" once the median time on any group of 5 consecutive patients was less than 3 seconds faster than the median time in the previous group of 5 consecutive patients, provided that there were no failed intubations or subsequent failed intubations using the same device.
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less than 5 minutes per intubation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joan L Robinson, MD, University of Alberta
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
January 1, 2007
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
October 4, 2010
First Submitted That Met QC Criteria
October 4, 2010
First Posted (Estimate)
October 6, 2010
Study Record Updates
Last Update Posted (Estimate)
October 8, 2012
Last Update Submitted That Met QC Criteria
October 5, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- JR-01
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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