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| Name | Class |
|---|---|
| Verathon | INDUSTRY |
| KARL STORZ Endoscopy-America, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| children intubated with Glidescope | children intubated with Glidescope |
| |
| children intubated with DCI | children intubated with DCI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| timed intubation | Procedure | timed intubation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria for Children Population:
- Children requiring intubation for elective or non-elective surgery
Exclusion Criteria:
Inclusion Criteria for Anesthesiologist Population:
*Anesthesiologists who care for children at Stollery Children's Hospital
Exclusion Criteria for Anesthesiologist Population:
*None
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Children being intubated for surgery
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| Name | Affiliation | Role |
|---|---|---|
| Joan L Robinson, MD | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stollery Children's Hospital | Edmonton | Alberta | T6G 2J3 | Canada |
Patients with anticipated difficult airways were excluded.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Baseline Intubation Participants | Children intubated at baseline using the standard laryngoscope blade of the anesthesiologist's choice. |
| FG002 | KS Intubation Participants | Children intubated with the Karl Storz Direct Coupled Interface DCI (KS) VLS |
| FG003 | GS Intubation Participants | Children intubated with the GlideScope system (GS) VLS |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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". | Only anesthesiologists who completed minimum 18 intubations with either laryngoscope were analyzed for the primary outcome. | Posted | Number | percent of anesthesiologists | Up to 5 minutes per intubation | intubations | Participants |
|
Duration of intubation attempt (maximum 5 minutes)
The incidence of trauma was recorded during the study. Failed intubation was one of the outcomes on the study so these events were not specifically recorded as adverse outcomes.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Traumatic intubation | Injury, poisoning and procedural complications | Systematic Assessment | Minor trauma was sustained on intubation attempts in two children at baseline, four with the GlideScope (GS) (on intubation attempts 5, 6, 8 and 18) and two with the Karl Storz Direct Coupled Interface(DCI)(KS) on intubation attempts 6 and 16). |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| DR. JOAN ROBINSON | UNIVERSITY OF ALBERTA | 780-248-5540 | jr3@ualberta.ca |
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| reported during intubation (up to 5 minutes) |
| 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 |
| Time to Intubation, Stratified by Weight of Patients | To compare the time-to-intubation for these laryngoscopes in children of different weights. | 4 years |
| 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) |
| 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 |
| Failed intubations |
|
| Did not complete all intubations |
|
| BG001 | Baseline Intubation Participants | Children intubated at baseline using the standard laryngoscope blade of the anesthesiologist's choice |
| BG002 | KS Intubation Participants | Children intubated with the Karl Storz Direct Coupled Interface (DCI) (KS) video laryngoscope (VLS) |
| BG003 | GS Intubaton Participants | Children intubated with the GlideScope system (GS) video laryngoscope (VLS) |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Gender of the children was not recorded as it was not thought to be of relevance for intubation participants. | Number | participants |
|
| OG001 | KS Intubations | Anesthesiologists who performed minimum 18 intubations with the KS VLS |
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|
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| 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. | Patients were excluded if the Cormack-Lehane score was not recorded. | Posted | Number | Percentage of participants | reported during intubation (up to 5 minutes) |
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| 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. | Only anesthesiologists who completed minimum 18 intubations with each scope were included. We report the mean of their mean times and the mean of their median times on intubations #16-20 when they should have attained a reasonable skill level. | Posted | Mean | Standard Deviation | seconds | 4 years | anesthesiologists | Participants |
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| Secondary | Time to Intubation, Stratified by Weight of Patients | To compare the time-to-intubation for these laryngoscopes in children of different weights. | Time to Intubation, Stratified by Weight of Patients | Posted | Mean | Standard Deviation | seconds | 4 years |
|
|
|
| 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 | Posted | Mean | Full Range | years | Baseline (assessed as of 2008) |
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| 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. | Posted | Number | participants | less than 5 minutes per intubation |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Baseline Intubation Participants | Children intubated at baseline using the standard laryngoscope blade of the anesthesiologist's choice | 0 | 249 | 2 | 249 |
| EG002 | KS Intubation Participants | Children intubated with the Karl Storz Direct Coupled Interface (DCI) (KS) video laryngoscope (VLS) | 0 | 196 | 2 | 196 |
| EG003 | GS Intubaton Participants | Children intubated with the GlideScope system (GS) video laryngoscope (VLS) | 0 | 201 | 4 | 201 |
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| Grade III |
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| Grade IV |
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| Average of mean times |
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| BOT occurred on intubations #11-15 |
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| BOT occurred on intubations #16-20 |
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| BOT not yet achieved |
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