Success of Pediatric Anesthesiologists in Learning to Use Videolaryngoscopes

Tracheal Intubation Morbidity Clinical Trial

Official title:

Anesthesiologists Learning to Use Videolaryngoscopes in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01215422
• Other study ID #: JR-01
• Status: Completed
• Phase: Phase 3
• First received: October 4, 2010
• Last updated: October 5, 2012
• Start date: January 2007
• Est. completion date: July 2011

Study information

• Verified date: October 2012
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 646
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

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 Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Tracheal Intubation Morbidity

Intervention

Procedure:
• timed intubation
timed intubation

Locations

Country	Name	City	State
Canada	Stollery Children's Hospital	Edmonton	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
University of Alberta	KARL STORZ Endoscopy-America, Inc., Verathon

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success in Learning to Use a Videolaryngoscope(VLS)	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	No
Secondary	Cormack & Lehane Score	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)	No
Secondary	Time to Intubation, Analyzed by Order of Laryngoscopes Used	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	No
Secondary	Time to Intubation, Stratified by Weight of Patients	To compare the time-to-intubation for these laryngoscopes in children of different weights.	4 years	No
Secondary	Mean Years Since Completion of Anesthesiology Residency	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)	No
Secondary	Number of Intubation Attempts to Reach "Best Obtainable Time to 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.	less than 5 minutes per intubation	No