Success of Pediatric Anesthesiologists in Learning to Use Videolaryngoscopes
This study has been completed.
Sponsor:
University of Alberta
Collaborators:
Verathon Inc.
KARL STORZ ENDOSCOPY-AMERICA, Inc.
Information provided by (Responsible Party):
Joan Robinson, University of Alberta
ClinicalTrials.gov Identifier:
NCT01215422
First received: October 4, 2010
Last updated: October 5, 2012
Last verified: October 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Results First Received: February 3, 2012
| Study Type: | Observational |
|---|---|
| Study Design: | Observational Model: Case-Crossover; Time Perspective: Prospective |
| Condition: |
Tracheal Intubation Morbidity |
| Intervention: |
Procedure: timed intubation |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Children were recruited pre-op if their anesthesiologist was participating in the study. Anesthesiologists did 20 baseline intubations with a standard laryngoscope and then were randomized to use the GlideScope(GS)or Karl Storz Direct Coupled Interface (KS) video laryngoscope (VLS) for 20 intubations), followed by the other VLS. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| Patients with anticipated difficult airways were excluded. |
Reporting Groups
| Description | |
|---|---|
| Overall Anesthesiologists | Baseline intubation times were obtained on a convenience sample of 20 children using the standard laryngoscope blade of their choice. Then anesthesiologists were randomized to complete either 20 intubations with the GlideScope system (GS) video laryngoscope (VLS) or 20 with the Karl Storz Direct Coupled Interface DCI (KS) VLS first. Once they had intubated 20 children with the VLS to which they were randomized, they crossed over to use the alternate VLS for 20 intubations. |
| Baseline Intubation Participants | Children intubated at baseline using the standard laryngoscope blade of the anesthesiologist's choice. |
| KS Intubation Participants | Children intubated with the Karl Storz Direct Coupled Interface DCI (KS) VLS |
| GS Intubation Participants | Children intubated with the GlideScope system (GS) VLS |
Participant Flow: Overall Study
| Overall Anesthesiologists | Baseline Intubation Participants | KS Intubation Participants | GS Intubation Participants | |
|---|---|---|---|---|
| STARTED | 14 | 249 | 196 | 201 |
| COMPLETED | 6 | 249 | 193 | 193 |
| NOT COMPLETED | 8 | 0 | 3 | 8 |
| Relocation | 1 | 0 | 0 | 0 |
| Failed intubations | 0 | 0 | 3 | 8 |
| Did not complete all intubations | 7 | 0 | 0 | 0 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Overall Anesthesiologists | Baseline intubation times were obtained on a convenience sample of 20 children using the standard laryngoscope blade of their choice. Then anesthesiologists were randomized to complete either 20 intubations with the GlideScope system (GS) video laryngoscope (VLS) or 20 with the Karl Storz Direct Coupled Interface DCI (KS) VLS first. Once they had intubated 20 children with the VLS to which they were randomized, they crossed over to use the alternate VLS for 20 intubations. |
| Baseline Intubation Participants | Children intubated at baseline using the standard laryngoscope blade of the anesthesiologist's choice |
| KS Intubation Participants | Children intubated with the Karl Storz Direct Coupled Interface (DCI) (KS) video laryngoscope (VLS) |
| GS Intubaton Participants | Children intubated with the GlideScope system (GS) video laryngoscope (VLS) |
| Total | Total of all reporting groups |
Baseline Measures
| Overall Anesthesiologists | Baseline Intubation Participants | KS Intubation Participants | GS Intubaton Participants | Total | |
|---|---|---|---|---|---|
|
Number of Participants
[units: participants] |
13 | 249 | 196 | 201 | 659 |
|
Age
[units: participants] |
|||||
| <=18 years | 0 | 249 | 196 | 201 | 646 |
| Between 18 and 65 years | 13 | 0 | 0 | 0 | 13 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
|
Gender, Customized
[1] [units: participants] |
|||||
| Unknown | 0 | 249 | 196 | 201 | 646 |
| Male | 6 | 0 | 0 | 0 | 6 |
| Female | 7 | 0 | 0 | 0 | 7 |
| [1] | Gender of the children was not recorded as it was not thought to be of relevance for intubation participants. |
|---|
Outcome Measures
| 1. Primary: | Success in Learning to Use a Videolaryngoscope(VLS) [ Time Frame: Up to 5 minutes per intubation ] |
| 2. Secondary: | Cormack & Lehane Score [ Time Frame: reported during intubation (up to 5 minutes) ] |
| 3. Secondary: | Time to Intubation, Analyzed by Order of Laryngoscopes Used [ Time Frame: 4 years ] |
| 4. Secondary: | Time to Intubation, Stratified by Weight of Patients [ Time Frame: 4 years ] |
| 5. Secondary: | Mean Years Since Completion of Anesthesiology Residency [ Time Frame: Baseline (assessed as of 2008) ] |
| 6. Secondary: | Number of Intubation Attempts to Reach "Best Obtainable Time to Intubation" [ Time Frame: less than 5 minutes per intubation ] |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| Principal Investigators are NOT employed by the organization sponsoring the study. |
| There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| Level of success could only be determined for the 8 anesthesiologists who completed minimum 18 intubations with the GS or KS video laryngoscope. Only 6 of 14 completed the whole study so had data could be used in comparing the two scopes. |
Results Point of Contact:
Name/Title: DR. JOAN ROBINSON
Organization: UNIVERSITY OF ALBERTA
phone: 780-248-5540
e-mail: jr3@ualberta.ca
Organization: UNIVERSITY OF ALBERTA
phone: 780-248-5540
e-mail: jr3@ualberta.ca
No publications provided
| Responsible Party: | Joan Robinson, University of Alberta |
| ClinicalTrials.gov Identifier: | NCT01215422 History of Changes |
| Other Study ID Numbers: | JR-01 |
| Study First Received: | October 4, 2010 |
| Results First Received: | February 3, 2012 |
| Last Updated: | October 5, 2012 |
| Health Authority: | Canada: Ethics Review Committee |