Trial Outcomes & Findings for Success of Pediatric Anesthesiologists in Learning to Use Videolaryngoscopes (NCT NCT01215422)
NCT ID: NCT01215422
Last Updated: 2012-10-08
Results Overview
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".
COMPLETED
646 participants
Up to 5 minutes per intubation
2012-10-08
Participant Flow
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.
Patients with anticipated difficult airways were excluded.
Participant milestones
| Measure |
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
249
|
196
|
201
|
|
Overall Study
COMPLETED
|
6
|
249
|
193
|
193
|
|
Overall Study
NOT COMPLETED
|
8
|
0
|
3
|
8
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|---|---|
|
Overall Study
Relocation
|
1
|
0
|
0
|
0
|
|
Overall Study
Failed intubations
|
0
|
0
|
3
|
8
|
|
Overall Study
Did not complete all intubations
|
7
|
0
|
0
|
0
|
Baseline Characteristics
Success of Pediatric Anesthesiologists in Learning to Use Videolaryngoscopes
Baseline characteristics by cohort
| Measure |
Overall Anesthesiologists
n=13 Participants
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
n=249 Participants
Children intubated at baseline using the standard laryngoscope blade of the anesthesiologist's choice
|
KS Intubation Participants
n=196 Participants
Children intubated with the Karl Storz Direct Coupled Interface (DCI) (KS) video laryngoscope (VLS)
|
GS Intubaton Participants
n=201 Participants
Children intubated with the GlideScope system (GS) video laryngoscope (VLS)
|
Total
n=659 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
249 Participants
n=4 Participants
|
196 Participants
n=27 Participants
|
201 Participants
n=483 Participants
|
646 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Sex/Gender, Customized
Unknown
|
0 participants
n=93 Participants
|
249 participants
n=4 Participants
|
196 participants
n=27 Participants
|
201 participants
n=483 Participants
|
646 participants
n=36 Participants
|
|
Sex/Gender, Customized
Male
|
6 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
6 participants
n=36 Participants
|
|
Sex/Gender, Customized
Female
|
7 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
7 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Up to 5 minutes per intubationPopulation: Only anesthesiologists who completed minimum 18 intubations with either laryngoscope were analyzed for the primary outcome.
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".
Outcome measures
| Measure |
GS Intubations
n=193 intubations
Anesthesiologists who performed minimum 18 intubations with the GS VLS.
|
KS Intubations
n=193 intubations
Anesthesiologists who performed minimum 18 intubations with the KS VLS
|
Baseline Intubation Participants
Children intubated at baseline using the standard laryngoscope of the anesthesiologist's choice
|
KS Intubation Times for Those Who Used GS First
|
|---|---|---|---|---|
|
Success in Learning to Use a Videolaryngoscope(VLS)
Rapid Success
|
37.5 percent of anesthesiologists
|
62.5 percent of anesthesiologists
|
—
|
—
|
|
Success in Learning to Use a Videolaryngoscope(VLS)
Delayed Success
|
25 percent of anesthesiologists
|
0 percent of anesthesiologists
|
—
|
—
|
|
Success in Learning to Use a Videolaryngoscope(VLS)
No Success
|
37.5 percent of anesthesiologists
|
37.5 percent of anesthesiologists
|
—
|
—
|
SECONDARY outcome
Timeframe: reported during intubation (up to 5 minutes)Population: Patients were excluded if the Cormack-Lehane score was not recorded.
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.
Outcome measures
| Measure |
GS Intubations
n=199 Participants
Anesthesiologists who performed minimum 18 intubations with the GS VLS.
|
KS Intubations
n=194 Participants
Anesthesiologists who performed minimum 18 intubations with the KS VLS
|
Baseline Intubation Participants
n=249 Participants
Children intubated at baseline using the standard laryngoscope of the anesthesiologist's choice
|
KS Intubation Times for Those Who Used GS First
|
|---|---|---|---|---|
|
Cormack & Lehane Score
Grade I
|
80.3 Percentage of participants
0.46
|
82.5 Percentage of participants
0.44
|
84.3 Percentage of participants
0.49
|
—
|
|
Cormack & Lehane Score
Grade II
|
19.7 Percentage of participants
|
16.5 Percentage of participants
|
12.0 Percentage of participants
|
—
|
|
Cormack & Lehane Score
Grade III
|
0 Percentage of participants
|
0.5 Percentage of participants
|
3.2 Percentage of participants
|
—
|
|
Cormack & Lehane Score
Grade IV
|
0 Percentage of participants
|
0 Percentage of participants
|
0.4 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 4 yearsPopulation: 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.
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.
Outcome measures
| Measure |
GS Intubations
n=3 anesthesiologists
Anesthesiologists who performed minimum 18 intubations with the GS VLS.
|
KS Intubations
n=3 anesthesiologists
Anesthesiologists who performed minimum 18 intubations with the KS VLS
|
Baseline Intubation Participants
n=3 anesthesiologists
Children intubated at baseline using the standard laryngoscope of the anesthesiologist's choice
|
KS Intubation Times for Those Who Used GS First
n=3 anesthesiologists
|
|---|---|---|---|---|
|
Time to Intubation, Analyzed by Order of Laryngoscopes Used
Average of median times
|
31.0 seconds
Standard Deviation 4.8
|
22.2 seconds
Standard Deviation 1.6
|
25.6 seconds
Standard Deviation 1.0
|
27.5 seconds
Standard Deviation 4.2
|
|
Time to Intubation, Analyzed by Order of Laryngoscopes Used
Average of mean times
|
30.7 seconds
Standard Deviation 4.5
|
23.7 seconds
Standard Deviation 2.4
|
27.4 seconds
Standard Deviation 2.3
|
30.8 seconds
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: 4 yearsPopulation: Time to Intubation, Stratified by Weight of Patients
To compare the time-to-intubation for these laryngoscopes in children of different weights.
Outcome measures
| Measure |
GS Intubations
n=193 Participants
Anesthesiologists who performed minimum 18 intubations with the GS VLS.
|
KS Intubations
n=193 Participants
Anesthesiologists who performed minimum 18 intubations with the KS VLS
|
Baseline Intubation Participants
n=249 Participants
Children intubated at baseline using the standard laryngoscope of the anesthesiologist's choice
|
KS Intubation Times for Those Who Used GS First
|
|---|---|---|---|---|
|
Time to Intubation, Stratified by Weight of Patients
< 10 kg Body Weight (n=12,9,32)
|
33.9 seconds
Standard Deviation 12.1
|
26.9 seconds
Standard Deviation 8.4
|
23.8 seconds
Standard Deviation 7.8
|
—
|
|
Time to Intubation, Stratified by Weight of Patients
>=10 kg Body Weight (n=181,184,217)
|
30.0 seconds
Standard Deviation 10.8
|
28.8 seconds
Standard Deviation 10.5
|
20.2 seconds
Standard Deviation 9.4
|
—
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
GS Intubations
n=7 Participants
Anesthesiologists who performed minimum 18 intubations with the GS VLS.
|
KS Intubations
n=6 Participants
Anesthesiologists who performed minimum 18 intubations with the KS VLS
|
Baseline Intubation Participants
Children intubated at baseline using the standard laryngoscope of the anesthesiologist's choice
|
KS Intubation Times for Those Who Used GS First
|
|---|---|---|---|---|
|
Mean Years Since Completion of Anesthesiology Residency
|
17 years
Interval 4.0 to 29.0
|
17 years
Interval 1.0 to 28.0
|
—
|
—
|
SECONDARY outcome
Timeframe: less than 5 minutes per intubationFor 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.
Outcome measures
| Measure |
GS Intubations
n=10 Participants
Anesthesiologists who performed minimum 18 intubations with the GS VLS.
|
KS Intubations
n=11 Participants
Anesthesiologists who performed minimum 18 intubations with the KS VLS
|
Baseline Intubation Participants
Children intubated at baseline using the standard laryngoscope of the anesthesiologist's choice
|
KS Intubation Times for Those Who Used GS First
|
|---|---|---|---|---|
|
Number of Intubation Attempts to Reach "Best Obtainable Time to Intubation"
BOT occurred on intubations #1-5
|
2 participants
|
4 participants
|
—
|
—
|
|
Number of Intubation Attempts to Reach "Best Obtainable Time to Intubation"
BOT occurred on intubations #6-10
|
1 participants
|
3 participants
|
—
|
—
|
|
Number of Intubation Attempts to Reach "Best Obtainable Time to Intubation"
BOT occurred on intubations #11-15
|
5 participants
|
1 participants
|
—
|
—
|
|
Number of Intubation Attempts to Reach "Best Obtainable Time to Intubation"
BOT occurred on intubations #16-20
|
2 participants
|
0 participants
|
—
|
—
|
|
Number of Intubation Attempts to Reach "Best Obtainable Time to Intubation"
BOT not yet achieved
|
0 participants
|
3 participants
|
—
|
—
|
Adverse Events
Overall Anesthesiologists
Baseline Intubation Participants
KS Intubation Participants
GS Intubaton Participants
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Overall Anesthesiologists
n=13 participants at risk
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
n=249 participants at risk
Children intubated at baseline using the standard laryngoscope blade of the anesthesiologist's choice
|
KS Intubation Participants
n=196 participants at risk
Children intubated with the Karl Storz Direct Coupled Interface (DCI) (KS) video laryngoscope (VLS)
|
GS Intubaton Participants
n=201 participants at risk
Children intubated with the GlideScope system (GS) video laryngoscope (VLS)
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Traumatic intubation
|
0.00%
0/13 • 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.
|
0.80%
2/249 • Number of events 2 • 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.
|
1.0%
2/196 • Number of events 2 • 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.
|
2.0%
4/201 • Number of events 4 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place