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Success of Pediatric Anesthesiologists in Learning to Use Videolaryngoscopes

Anesthesiologists Learning to Use Videolaryngoscopes in Children

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01215422
Enrollment
646
Registered
2010-10-06
Start date
2007-01-31
Completion date
2011-07-31
Last updated
2012-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tracheal Intubation Morbidity

Keywords

Surgical procedures, Intubation, Anesthesiologist, Laryngoscope, Videolaryngoscope

Brief 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.

Detailed 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.

Interventions

PROCEDUREtimed intubation

timed intubation

Sponsors

Verathon
CollaboratorINDUSTRY
KARL STORZ Endoscopy-America, Inc.
CollaboratorINDUSTRY
University of Alberta
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Success in Learning to Use a Videolaryngoscope(VLS)Up to 5 minutes per intubationAnesthesiologists 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

MeasureTime frameDescription
Cormack & Lehane Scorereported 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.
Time to Intubation, Analyzed by Order of Laryngoscopes Used4 yearsTo 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.
Time to Intubation, Stratified by Weight of Patients4 yearsTo compare the time-to-intubation for these laryngoscopes in children of different weights.
Mean Years Since Completion of Anesthesiology ResidencyBaseline (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
Number of Intubation Attempts to Reach Best Obtainable Time to Intubationless 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.

Countries

Canada

Participant flow

Recruitment details

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

Patients with anticipated difficult airways were excluded.

Participants by arm

ArmCount
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.
13
Baseline Intubation Participants
Children intubated at baseline using the standard laryngoscope blade of the anesthesiologist's choice
249
KS Intubation Participants
Children intubated with the Karl Storz Direct Coupled Interface (DCI) (KS) video laryngoscope (VLS)
196
GS Intubaton Participants
Children intubated with the GlideScope system (GS) video laryngoscope (VLS)
201
Total659

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyDid not complete all intubations7000
Overall StudyFailed intubations0038
Overall StudyRelocation1000

Baseline characteristics

CharacteristicTotalOverall AnesthesiologistsBaseline Intubation ParticipantsKS Intubation ParticipantsGS Intubaton Participants
Age, Categorical
<=18 years
646 Participants0 Participants249 Participants196 Participants201 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
13 Participants13 Participants0 Participants0 Participants0 Participants
Sex/Gender, Customized
Female
7 participants7 participants0 participants0 participants0 participants
Sex/Gender, Customized
Male
6 participants6 participants0 participants0 participants0 participants
Sex/Gender, Customized
Unknown
646 participants0 participants249 participants196 participants201 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
0 / 132 / 2492 / 1964 / 201
serious
Total, serious adverse events
0 / 130 / 2490 / 1960 / 201

Outcome results

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.

Time frame: Up to 5 minutes per intubation

Population: Only anesthesiologists who completed minimum 18 intubations with either laryngoscope were analyzed for the primary outcome.

ArmMeasureGroupValue (NUMBER)
GS IntubationsSuccess in Learning to Use a Videolaryngoscope(VLS)Rapid Success37.5 percent of anesthesiologists
GS IntubationsSuccess in Learning to Use a Videolaryngoscope(VLS)No Success37.5 percent of anesthesiologists
GS IntubationsSuccess in Learning to Use a Videolaryngoscope(VLS)Delayed Success25 percent of anesthesiologists
KS IntubationsSuccess in Learning to Use a Videolaryngoscope(VLS)No Success37.5 percent of anesthesiologists
KS IntubationsSuccess in Learning to Use a Videolaryngoscope(VLS)Rapid Success62.5 percent of anesthesiologists
KS IntubationsSuccess in Learning to Use a Videolaryngoscope(VLS)Delayed Success0 percent of anesthesiologists
p-value: >0.05Regression, Logistic
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.

Time frame: reported during intubation (up to 5 minutes)

Population: Patients were excluded if the Cormack-Lehane score was not recorded.

ArmMeasureGroupValue (NUMBER)Dispersion
GS IntubationsCormack & Lehane ScoreGrade III0 Percentage of participants
GS IntubationsCormack & Lehane ScoreGrade II19.7 Percentage of participants
GS IntubationsCormack & Lehane ScoreGrade I80.3 Percentage of participants 0.46
GS IntubationsCormack & Lehane ScoreGrade IV0 Percentage of participants
KS IntubationsCormack & Lehane ScoreGrade II16.5 Percentage of participants
KS IntubationsCormack & Lehane ScoreGrade IV0 Percentage of participants
KS IntubationsCormack & Lehane ScoreGrade I82.5 Percentage of participants 0.44
KS IntubationsCormack & Lehane ScoreGrade III0.5 Percentage of participants
Baseline Intubation ParticipantsCormack & Lehane ScoreGrade I84.3 Percentage of participants 0.49
Baseline Intubation ParticipantsCormack & Lehane ScoreGrade IV0.4 Percentage of participants
Baseline Intubation ParticipantsCormack & Lehane ScoreGrade III3.2 Percentage of participants
Baseline Intubation ParticipantsCormack & Lehane ScoreGrade II12.0 Percentage of participants
p-value: 0.03Fisher Exact
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

Time frame: Baseline (assessed as of 2008)

ArmMeasureValue (MEAN)
GS IntubationsMean Years Since Completion of Anesthesiology Residency17 years
KS IntubationsMean Years Since Completion of Anesthesiology Residency17 years
p-value: >0.05Correlation
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.

Time frame: less than 5 minutes per intubation

ArmMeasureGroupValue (NUMBER)
GS IntubationsNumber of Intubation Attempts to Reach Best Obtainable Time to IntubationBOT occurred on intubations #1-52 participants
GS IntubationsNumber of Intubation Attempts to Reach Best Obtainable Time to IntubationBOT occurred on intubations #6-101 participants
GS IntubationsNumber of Intubation Attempts to Reach Best Obtainable Time to IntubationBOT occurred on intubations #11-155 participants
GS IntubationsNumber of Intubation Attempts to Reach Best Obtainable Time to IntubationBOT occurred on intubations #16-202 participants
GS IntubationsNumber of Intubation Attempts to Reach Best Obtainable Time to IntubationBOT not yet achieved0 participants
KS IntubationsNumber of Intubation Attempts to Reach Best Obtainable Time to IntubationBOT occurred on intubations #11-151 participants
KS IntubationsNumber of Intubation Attempts to Reach Best Obtainable Time to IntubationBOT occurred on intubations #1-54 participants
KS IntubationsNumber of Intubation Attempts to Reach Best Obtainable Time to IntubationBOT occurred on intubations #16-200 participants
KS IntubationsNumber of Intubation Attempts to Reach Best Obtainable Time to IntubationBOT occurred on intubations #6-103 participants
KS IntubationsNumber of Intubation Attempts to Reach Best Obtainable Time to IntubationBOT not yet achieved3 participants
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.

Time frame: 4 years

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
GS IntubationsTime to Intubation, Analyzed by Order of Laryngoscopes UsedAverage of mean times30.7 secondsStandard Deviation 4.5
GS IntubationsTime to Intubation, Analyzed by Order of Laryngoscopes UsedAverage of median times31.0 secondsStandard Deviation 4.8
KS IntubationsTime to Intubation, Analyzed by Order of Laryngoscopes UsedAverage of mean times23.7 secondsStandard Deviation 2.4
KS IntubationsTime to Intubation, Analyzed by Order of Laryngoscopes UsedAverage of median times22.2 secondsStandard Deviation 1.6
Baseline Intubation ParticipantsTime to Intubation, Analyzed by Order of Laryngoscopes UsedAverage of median times25.6 secondsStandard Deviation 1
Baseline Intubation ParticipantsTime to Intubation, Analyzed by Order of Laryngoscopes UsedAverage of mean times27.4 secondsStandard Deviation 2.3
KS Intubation Times for Those Who Used GS FirstTime to Intubation, Analyzed by Order of Laryngoscopes UsedAverage of median times27.5 secondsStandard Deviation 4.2
KS Intubation Times for Those Who Used GS FirstTime to Intubation, Analyzed by Order of Laryngoscopes UsedAverage of mean times30.8 secondsStandard Deviation 5.2
Secondary

Time to Intubation, Stratified by Weight of Patients

To compare the time-to-intubation for these laryngoscopes in children of different weights.

Time frame: 4 years

Population: Time to Intubation, Stratified by Weight of Patients

ArmMeasureGroupValue (MEAN)Dispersion
GS IntubationsTime to Intubation, Stratified by Weight of Patients< 10 kg Body Weight (n=12,9,32)33.9 secondsStandard Deviation 12.1
GS IntubationsTime to Intubation, Stratified by Weight of Patients>=10 kg Body Weight (n=181,184,217)30.0 secondsStandard Deviation 10.8
KS IntubationsTime to Intubation, Stratified by Weight of Patients>=10 kg Body Weight (n=181,184,217)28.8 secondsStandard Deviation 10.5
KS IntubationsTime to Intubation, Stratified by Weight of Patients< 10 kg Body Weight (n=12,9,32)26.9 secondsStandard Deviation 8.4
Baseline Intubation ParticipantsTime to Intubation, Stratified by Weight of Patients< 10 kg Body Weight (n=12,9,32)23.8 secondsStandard Deviation 7.8
Baseline Intubation ParticipantsTime to Intubation, Stratified by Weight of Patients>=10 kg Body Weight (n=181,184,217)20.2 secondsStandard Deviation 9.4

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026