Surgeries Undergoing General Anesthesia
Conditions
Brief summary
The purpose of this study is to compare: the standard pediatric intubation instrument (Miller blade) used as direct laryngoscopy during tracheal intubation to the VideoMiller device (the standard pediatric blade with a camera attached, giving indirect view of the vocal cords in the screen). This intubation device is used to place the tube in the trachea to keep the patient breathing during the surgery procedure. The anesthesiologist obtains a better view of the vocal cords looking at the screen provided by the VideoMiller.
Interventions
DEVICEVideoMiller
Video-Miller laryngoscope, using the screen (Video laryngoscopy group)
DEVICEDirect Laryngoscopy
Video-Miller laryngoscope, without screen (Direct laryngoscopy group)
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Years
Healthy volunteers
No
Inclusion criteria
1. Patients aged 3 years or younger undergoing anesthesia requiring endotracheal intubation. 2. Obtaining signed the informed consent by their parents or legal guardian. 3. American Society of Anaesthesiologists (ASA) physical status classification I - II or III
Exclusion criteria
1. Patients deemed to be at significant airway risk necessitating an awake fiber optic intubation 2. Patients with facial abnormalities, and/or oral-pharyngeal malformation. 3. Emergency operation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Obtain Glottic View | Times following initial insertion of laryngoscope blade to obtain glottic view | Time to obtain glottic view (from initial insertion of laryngoscope blade to obtain glottic view) |
| Intubation Time | Times from insertion of laryngoscope blade to placement of tracheal tube | Times following initial insertion of laryngoscope blade to placement of tracheal tube |
| Time From Insertion of Laryngoscope Blade to Confirm w/ CO2 Waveform | Time from initial insertion of laryngoscope blade to confirm w/ CO2 waveform | Time following initial insertion of laryngoscope blade to confirm w/ CO2 waveform |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glottis Visualization Using POGO Score | During intubation procedure, up to 3 minutes | POGO score represents the percentage of glottic opening seen (from 0-100%) |
| Glottis Visualization Using Cormack Lehane | During intubation procedure, up to 3 minutes | Glottic visualization comparison between the two devices. Grade Description Approximate frequency Likelihood of difficult intubation 1. Full view of glottis 68-74% \<1% 2. a Partial view of glottis 21-24% 4.3-13.4% 2b Only posterior extremity of glottis seen or only arytenoid cartilages 3.3-6.5% 65-67.4% 3 Only epiglottis seen, none of glottis seen 1.2-1.6% 80-87.5% 4 Neither glottis nor epiglottis seen very rare |
| Number of Participants Intubated With 1 and > 1 Intubation Attempts | During intubation procedure, up to 3 minutes | Number of Participants intubated after 1 intubation attempt and Number of Participants intubated after \> 1 intubation attempts |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Video-Miller Laryngoscope using the screen (Video laryngoscopy group)
VideoMiller: Video-Miller laryngoscope, using the screen (Video laryngoscopy group) | 14 |
| Direct Laryngoscopy without use the screen (Direct laryngoscopy group)
Direct Laryngoscopy: Video-Miller laryngoscope, without screen (Direct laryngoscopy group) | 14 |
| Total | 28 |
Baseline characteristics
| Characteristic | Video-Miller Laryngoscope | Direct Laryngoscopy | Total |
|---|---|---|---|
| Age, Continuous | 7.6 months STANDARD_DEVIATION 4 | 9.6 months STANDARD_DEVIATION 7 | 8 months STANDARD_DEVIATION 5 |
| Height | 71 cm STANDARD_DEVIATION 13 | 69 cm STANDARD_DEVIATION 13 | 70 cm STANDARD_DEVIATION 13 |
| Laryngoscope Blade Size Laryngoscope Blade size 0 | 12 Count of Participants | 13 Count of Participants | 25 Count of Participants |
| Laryngoscope Blade Size Laryngoscope Blade size 1 | 2 Count of Participants | 1 Count of Participants | 3 Count of Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Caucasian | 11 Participants | 14 Participants | 25 Participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 16 Participants |
| Weight | 8 Kg STANDARD_DEVIATION 3 | 10 Kg STANDARD_DEVIATION 4 | 9 Kg STANDARD_DEVIATION 3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 0 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
Primary
Intubation Time
Times following initial insertion of laryngoscope blade to placement of tracheal tube
Time frame: Times from insertion of laryngoscope blade to placement of tracheal tube
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Video-Miller Laryngoscope | Intubation Time | 21 Seconds | Standard Deviation 11 |
| Direct Laryngoscopy | Intubation Time | 28 Seconds | Standard Deviation 20 |
Primary
Time From Insertion of Laryngoscope Blade to Confirm w/ CO2 Waveform
Time following initial insertion of laryngoscope blade to confirm w/ CO2 waveform
Time frame: Time from initial insertion of laryngoscope blade to confirm w/ CO2 waveform
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Video-Miller Laryngoscope | Time From Insertion of Laryngoscope Blade to Confirm w/ CO2 Waveform | 61 seconds | Standard Deviation 37 |
| Direct Laryngoscopy | Time From Insertion of Laryngoscope Blade to Confirm w/ CO2 Waveform | 59 seconds | Standard Deviation 30 |
Primary
Time to Obtain Glottic View
Time to obtain glottic view (from initial insertion of laryngoscope blade to obtain glottic view)
Time frame: Times following initial insertion of laryngoscope blade to obtain glottic view
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Video-Miller Laryngoscope | Time to Obtain Glottic View | 9.2 seconds | Standard Deviation 5 |
| Direct Laryngoscopy | Time to Obtain Glottic View | 8.4 seconds | Standard Deviation 6.4 |
Secondary
Glottis Visualization Using Cormack Lehane
Glottic visualization comparison between the two devices. Grade Description Approximate frequency Likelihood of difficult intubation 1. Full view of glottis 68-74% \<1% 2. a Partial view of glottis 21-24% 4.3-13.4% 2b Only posterior extremity of glottis seen or only arytenoid cartilages 3.3-6.5% 65-67.4% 3 Only epiglottis seen, none of glottis seen 1.2-1.6% 80-87.5% 4 Neither glottis nor epiglottis seen very rare
Time frame: During intubation procedure, up to 3 minutes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Video-Miller Laryngoscope | Glottis Visualization Using Cormack Lehane | Cormack Lehane score 1 | 12 Count of Participants |
| Video-Miller Laryngoscope | Glottis Visualization Using Cormack Lehane | Cormack Lehane score 2 | 2 Count of Participants |
| Direct Laryngoscopy | Glottis Visualization Using Cormack Lehane | Cormack Lehane score 1 | 12 Count of Participants |
| Direct Laryngoscopy | Glottis Visualization Using Cormack Lehane | Cormack Lehane score 2 | 2 Count of Participants |
Secondary
Glottis Visualization Using POGO Score
POGO score represents the percentage of glottic opening seen (from 0-100%)
Time frame: During intubation procedure, up to 3 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Video-Miller Laryngoscope | Glottis Visualization Using POGO Score | 94 percentage of glottic opening | Standard Deviation 5.6 |
| Direct Laryngoscopy | Glottis Visualization Using POGO Score | 93.2 percentage of glottic opening | Standard Deviation 14 |
Secondary
Number of Participants Intubated With 1 and > 1 Intubation Attempts
Number of Participants intubated after 1 intubation attempt and Number of Participants intubated after \> 1 intubation attempts
Time frame: During intubation procedure, up to 3 minutes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Video-Miller Laryngoscope | Number of Participants Intubated With 1 and > 1 Intubation Attempts | Intubation attempt= 1 | 11 participants |
| Video-Miller Laryngoscope | Number of Participants Intubated With 1 and > 1 Intubation Attempts | Intubation attempts > 1 | 3 participants |
| Direct Laryngoscopy | Number of Participants Intubated With 1 and > 1 Intubation Attempts | Intubation attempt= 1 | 12 participants |
| Direct Laryngoscopy | Number of Participants Intubated With 1 and > 1 Intubation Attempts | Intubation attempts > 1 | 2 participants |