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Completed

NCT Number: NCT01215422

Success of Pediatric Anesthesiologists in Learning to Use Videolaryngoscopes

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.

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Key information

Conditions

Tracheal Intubation Morbidity

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Stollery Children's Hospital

Edmonton, Alberta, T6G 2J3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

timed intubation

Procedure

timed intubation

Primary outcomes

  1. 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".

Secondary outcomes

  1. 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.

  2. 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.

  3. 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. 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

  5. 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.

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • KARL STORZ Endoscopy-America, Inc.
  • Verathon

Registry information

Official study title

Anesthesiologists Learning to Use Videolaryngoscopes in Children

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Oct 6, 2010
Registry last updated
Oct 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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