Tracheal Intubation Morbidity
Conditions
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
timed intubation
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Success in Learning to Use a Videolaryngoscope(VLS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Cormack & Lehane Score | 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. |
| Time to Intubation, Analyzed by Order of Laryngoscopes Used | 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. |
| Time to Intubation, Stratified by Weight of Patients | 4 years | To compare the time-to-intubation for these laryngoscopes in children of different weights. |
| Mean Years Since Completion of Anesthesiology Residency | 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 |
| Number of Intubation Attempts to Reach Best Obtainable Time to Intubation | 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. |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 659 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Did not complete all intubations | 7 | 0 | 0 | 0 |
| Overall Study | Failed intubations | 0 | 0 | 3 | 8 |
| Overall Study | Relocation | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Overall Anesthesiologists | Baseline Intubation Participants | KS Intubation Participants | GS Intubaton Participants |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 646 Participants | 0 Participants | 249 Participants | 196 Participants | 201 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 13 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Female | 7 participants | 7 participants | 0 participants | 0 participants | 0 participants |
| Sex/Gender, Customized Male | 6 participants | 6 participants | 0 participants | 0 participants | 0 participants |
| Sex/Gender, Customized Unknown | 646 participants | 0 participants | 249 participants | 196 participants | 201 participants |
Adverse events
| Event type | EG000 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 / 13 | 2 / 249 | 2 / 196 | 4 / 201 |
| serious Total, serious adverse events | 0 / 13 | 0 / 249 | 0 / 196 | 0 / 201 |
Outcome results
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GS Intubations | Success in Learning to Use a Videolaryngoscope(VLS) | Rapid Success | 37.5 percent of anesthesiologists |
| GS Intubations | Success in Learning to Use a Videolaryngoscope(VLS) | No Success | 37.5 percent of anesthesiologists |
| GS Intubations | Success in Learning to Use a Videolaryngoscope(VLS) | Delayed Success | 25 percent of anesthesiologists |
| KS Intubations | Success in Learning to Use a Videolaryngoscope(VLS) | No Success | 37.5 percent of anesthesiologists |
| KS Intubations | Success in Learning to Use a Videolaryngoscope(VLS) | Rapid Success | 62.5 percent of anesthesiologists |
| KS Intubations | Success in Learning to Use a Videolaryngoscope(VLS) | Delayed Success | 0 percent of anesthesiologists |
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.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| GS Intubations | Cormack & Lehane Score | Grade III | 0 Percentage of participants | — |
| GS Intubations | Cormack & Lehane Score | Grade II | 19.7 Percentage of participants | — |
| GS Intubations | Cormack & Lehane Score | Grade I | 80.3 Percentage of participants | 0.46 |
| GS Intubations | Cormack & Lehane Score | Grade IV | 0 Percentage of participants | — |
| KS Intubations | Cormack & Lehane Score | Grade II | 16.5 Percentage of participants | — |
| KS Intubations | Cormack & Lehane Score | Grade IV | 0 Percentage of participants | — |
| KS Intubations | Cormack & Lehane Score | Grade I | 82.5 Percentage of participants | 0.44 |
| KS Intubations | Cormack & Lehane Score | Grade III | 0.5 Percentage of participants | — |
| Baseline Intubation Participants | Cormack & Lehane Score | Grade I | 84.3 Percentage of participants | 0.49 |
| Baseline Intubation Participants | Cormack & Lehane Score | Grade IV | 0.4 Percentage of participants | — |
| Baseline Intubation Participants | Cormack & Lehane Score | Grade III | 3.2 Percentage of participants | — |
| Baseline Intubation Participants | Cormack & Lehane Score | Grade II | 12.0 Percentage of participants | — |
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)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GS Intubations | Mean Years Since Completion of Anesthesiology Residency | 17 years |
| KS Intubations | Mean Years Since Completion of Anesthesiology Residency | 17 years |
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GS Intubations | Number of Intubation Attempts to Reach Best Obtainable Time to Intubation | BOT occurred on intubations #1-5 | 2 participants |
| GS Intubations | Number of Intubation Attempts to Reach Best Obtainable Time to Intubation | BOT occurred on intubations #6-10 | 1 participants |
| GS Intubations | Number of Intubation Attempts to Reach Best Obtainable Time to Intubation | BOT occurred on intubations #11-15 | 5 participants |
| GS Intubations | Number of Intubation Attempts to Reach Best Obtainable Time to Intubation | BOT occurred on intubations #16-20 | 2 participants |
| GS Intubations | Number of Intubation Attempts to Reach Best Obtainable Time to Intubation | BOT not yet achieved | 0 participants |
| KS Intubations | Number of Intubation Attempts to Reach Best Obtainable Time to Intubation | BOT occurred on intubations #11-15 | 1 participants |
| KS Intubations | Number of Intubation Attempts to Reach Best Obtainable Time to Intubation | BOT occurred on intubations #1-5 | 4 participants |
| KS Intubations | Number of Intubation Attempts to Reach Best Obtainable Time to Intubation | BOT occurred on intubations #16-20 | 0 participants |
| KS Intubations | Number of Intubation Attempts to Reach Best Obtainable Time to Intubation | BOT occurred on intubations #6-10 | 3 participants |
| KS Intubations | Number of Intubation Attempts to Reach Best Obtainable Time to Intubation | BOT not yet achieved | 3 participants |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GS Intubations | Time to Intubation, Analyzed by Order of Laryngoscopes Used | Average of mean times | 30.7 seconds | Standard Deviation 4.5 |
| GS Intubations | Time to Intubation, Analyzed by Order of Laryngoscopes Used | Average of median times | 31.0 seconds | Standard Deviation 4.8 |
| KS Intubations | Time to Intubation, Analyzed by Order of Laryngoscopes Used | Average of mean times | 23.7 seconds | Standard Deviation 2.4 |
| KS Intubations | Time to Intubation, Analyzed by Order of Laryngoscopes Used | Average of median times | 22.2 seconds | Standard Deviation 1.6 |
| Baseline Intubation Participants | Time to Intubation, Analyzed by Order of Laryngoscopes Used | Average of median times | 25.6 seconds | Standard Deviation 1 |
| Baseline Intubation Participants | Time to Intubation, Analyzed by Order of Laryngoscopes Used | Average of mean times | 27.4 seconds | Standard Deviation 2.3 |
| KS Intubation Times for Those Who Used GS First | Time to Intubation, Analyzed by Order of Laryngoscopes Used | Average of median times | 27.5 seconds | Standard Deviation 4.2 |
| KS Intubation Times for Those Who Used GS First | Time to Intubation, Analyzed by Order of Laryngoscopes Used | Average of mean times | 30.8 seconds | Standard Deviation 5.2 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GS Intubations | Time to Intubation, Stratified by Weight of Patients | < 10 kg Body Weight (n=12,9,32) | 33.9 seconds | Standard Deviation 12.1 |
| GS Intubations | Time to Intubation, Stratified by Weight of Patients | >=10 kg Body Weight (n=181,184,217) | 30.0 seconds | Standard Deviation 10.8 |
| KS Intubations | Time to Intubation, Stratified by Weight of Patients | >=10 kg Body Weight (n=181,184,217) | 28.8 seconds | Standard Deviation 10.5 |
| KS Intubations | Time to Intubation, Stratified by Weight of Patients | < 10 kg Body Weight (n=12,9,32) | 26.9 seconds | Standard Deviation 8.4 |
| Baseline Intubation Participants | Time to Intubation, Stratified by Weight of Patients | < 10 kg Body Weight (n=12,9,32) | 23.8 seconds | Standard Deviation 7.8 |
| Baseline Intubation Participants | Time to Intubation, Stratified by Weight of Patients | >=10 kg Body Weight (n=181,184,217) | 20.2 seconds | Standard Deviation 9.4 |