Obesity
Conditions
Keywords
Direct Laryngoscopy, Video-Mac, GlideScope, McGrath, Laryngoscopy, Bariatrics, Glottic view, Airway intubating devices, Tracheal intubation
Brief summary
This prospective, randomized study will compare the effectiveness of 4 different airway intubating devices which are most commonly used. The four different devices are as follows: McGrath video laryngoscope, GlideScope video laryngoscope, Video-Mac video laryngoscope, and Macintosh size 4 direct laryngoscope.
Detailed description
Hypothesis: the use of a video laryngoscope will improve the glottic view compared to direct laryngoscopy, and secondarily, use of the video laryngoscope will reduce the time required to achieve successful tracheal intubation in patients undergoing bariatric surgery. (Weight loss surgery). The three types of video laryngoscopy devices include; the Verethon GlideScope, LMA McGrath and Karl-Storz Video-Mac.
Interventions
DEVICEMcGrath
Intubation with the McGrath device
DEVICEGlideScope
Intubation with the GlideScope device
DEVICEDirect Macintosh Laryngoscopy
Intubation with Direct Macintosh Laryngoscope
DEVICEVideo-Mac
Intubation with the Video-Mac device
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with a documented body mass index (BMI) of \>35. * Patients scheduled to undergo inpatient surgery procedures under general anesthesia. * Willingness and ability to sign an informed consent document * 18 - 80 years of age * American Society of Anesthesiologists (ASA) Class II- III adults of either sex.
Exclusion criteria
* Patients who are deemed to be such a significant of an airway risk that they necessitate awake fiberoptic intubation * Patients with a history facial abnormalities, oral-pharyngeal cancer or reconstructive surgery * Emergency surgeries * Pregnancy * The inability to tolerate 0.2mg of glycopyrrolate based on tachycardia. * Any other conditions or use of any medication which may interfere with the conduct of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intubation Time Using a Stop Watch | up to 3 minutes | Evaluate if the time it takes to achieve successful tracheal intubation in patients undergoing bariatric surgery (weight loss surgery) will be reduced using the video-mac, glidescope, and McGrath vs direct laryngoscopy. |
| Time to Obtain Glottis Visualization (Seconds) | up to 1 minute | It is the time (seconds) following initial insertion of laryngoscope blade to obtain a glottic view. Start of intubation procedure to Glottic view (the opening between the vocal cords at the upper part of the larynx) visualization comparison between the four devices in patients undergoing bariatric surgery |
| Percentage of Glottic Opening (POGO) [%] | up to 1 minute | POGO score of 100% denotes visualization of the entire glottic opening in linear fashion from the anterior commissure to the posterior cartilages. If none of the glottic opening is seen, then the POGO score is 0%. View of the glottic opening (0-100%) during the intubation process. |
| Glottis View Using the Cormack Lehane Score | Up to 1 minute | Cormack Lehane score classification: Grade 1: Most of the glottis is visible Grade 2: At best almost half of the glottis is seen, at worst only the posterior tip of the arytenoids is seen Grade 3: Only the epiglottis is visible Grade 4: No laryngeal structures are visible |
Countries
United States
Participant flow
Recruitment details
Obese patients (ASA II-III) undergoing bariatric surgery (e.g., laparoscopic gastric band placement, laparoscopic Roux-EN-Y gastric bypass laparoscopic) requiring orotracheal intubation were randomly assigned to one of four study groups. Enrollment from May 2010 to February 2012.
Participants by arm
| Arm | Count |
|---|---|
| Direct Macintosh Laryngoscopy Direct Macintosh Laryngoscope device | 31 |
| Video-Mac Video-Mac device | 30 |
| GlideScope GlideScope device | 30 |
| McGrath MacGrath device | 30 |
| Total | 121 |
Baseline characteristics
| Characteristic | Direct Macintosh Laryngoscopy | Video-Mac | GlideScope | McGrath | Total |
|---|---|---|---|---|---|
| Age, Continuous | 46 Years STANDARD_DEVIATION 12 | 44 Years STANDARD_DEVIATION 12 | 45 Years STANDARD_DEVIATION 12 | 45 Years STANDARD_DEVIATION 12 | 45 Years STANDARD_DEVIATION 12 |
| Body Mass Index (BMI) | 42 kg/m^2 STANDARD_DEVIATION 5 | 43 kg/m^2 STANDARD_DEVIATION 8 | 43 kg/m^2 STANDARD_DEVIATION 5 | 41 kg/m^2 STANDARD_DEVIATION 6 | 42 kg/m^2 STANDARD_DEVIATION 6 |
| Sex: Female, Male Female | 23 Participants | 23 Participants | 23 Participants | 20 Participants | 89 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 7 Participants | 10 Participants | 32 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 / 30 | 0 / 30 | 0 / 30 | 0 / 31 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 31 |
Outcome results
Primary
Glottis View Using the Cormack Lehane Score
Cormack Lehane score classification: Grade 1: Most of the glottis is visible Grade 2: At best almost half of the glottis is seen, at worst only the posterior tip of the arytenoids is seen Grade 3: Only the epiglottis is visible Grade 4: No laryngeal structures are visible
Time frame: Up to 1 minute
Population: Cormack Lehane score (grade:1/2/3/4 \[n\])
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Direct Macintosh Laryngoscopy | Glottis View Using the Cormack Lehane Score | Grade 4 | 6 participants |
| Direct Macintosh Laryngoscopy | Glottis View Using the Cormack Lehane Score | Grade 1 | 12 participants |
| Direct Macintosh Laryngoscopy | Glottis View Using the Cormack Lehane Score | Grade 3 | 5 participants |
| Direct Macintosh Laryngoscopy | Glottis View Using the Cormack Lehane Score | Grade 2 | 8 participants |
| Video-Mac | Glottis View Using the Cormack Lehane Score | Grade 1 | 16 participants |
| Video-Mac | Glottis View Using the Cormack Lehane Score | Grade 3 | 2 participants |
| Video-Mac | Glottis View Using the Cormack Lehane Score | Grade 2 | 12 participants |
| Video-Mac | Glottis View Using the Cormack Lehane Score | Grade 4 | 0 participants |
| GlideScope | Glottis View Using the Cormack Lehane Score | Grade 4 | 0 participants |
| GlideScope | Glottis View Using the Cormack Lehane Score | Grade 1 | 18 participants |
| GlideScope | Glottis View Using the Cormack Lehane Score | Grade 3 | 2 participants |
| GlideScope | Glottis View Using the Cormack Lehane Score | Grade 2 | 10 participants |
| McGrath | Glottis View Using the Cormack Lehane Score | Grade 4 | 0 participants |
| McGrath | Glottis View Using the Cormack Lehane Score | Grade 1 | 23 participants |
| McGrath | Glottis View Using the Cormack Lehane Score | Grade 3 | 0 participants |
| McGrath | Glottis View Using the Cormack Lehane Score | Grade 2 | 7 participants |
Primary
Intubation Time Using a Stop Watch
Evaluate if the time it takes to achieve successful tracheal intubation in patients undergoing bariatric surgery (weight loss surgery) will be reduced using the video-mac, glidescope, and McGrath vs direct laryngoscopy.
Time frame: up to 3 minutes
Population: Times following initial insertion of laryngoscope blade:~to obtain glottic view (sec) to placement of tracheal tube (sec) to confirm with CO2 waveform (sec)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Direct Macintosh Laryngoscopy | Intubation Time Using a Stop Watch | Time to placement of tracheal tube | 43 Seconds | Standard Deviation 44 |
| Direct Macintosh Laryngoscopy | Intubation Time Using a Stop Watch | Time to confirm with CO2 waveform | 70 Seconds | Standard Deviation 43 |
| Video-Mac | Intubation Time Using a Stop Watch | Time to confirm with CO2 waveform | 49 Seconds | Standard Deviation 25 |
| Video-Mac | Intubation Time Using a Stop Watch | Time to placement of tracheal tube | 22 Seconds | Standard Deviation 15 |
| GlideScope | Intubation Time Using a Stop Watch | Time to placement of tracheal tube | 45 Seconds | Standard Deviation 32 |
| GlideScope | Intubation Time Using a Stop Watch | Time to confirm with CO2 waveform | 69 Seconds | Standard Deviation 34 |
| McGrath | Intubation Time Using a Stop Watch | Time to placement of tracheal tube | 40 Seconds | Standard Deviation 32 |
| McGrath | Intubation Time Using a Stop Watch | Time to confirm with CO2 waveform | 62 Seconds | Standard Deviation 31 |
Primary
Percentage of Glottic Opening (POGO) [%]
POGO score of 100% denotes visualization of the entire glottic opening in linear fashion from the anterior commissure to the posterior cartilages. If none of the glottic opening is seen, then the POGO score is 0%. View of the glottic opening (0-100%) during the intubation process.
Time frame: up to 1 minute
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Direct Macintosh Laryngoscopy | Percentage of Glottic Opening (POGO) [%] | 57 percentage of glottis opening | Standard Deviation 41 |
| Video-Mac | Percentage of Glottic Opening (POGO) [%] | 84 percentage of glottis opening | Standard Deviation 20 |
| GlideScope | Percentage of Glottic Opening (POGO) [%] | 87 percentage of glottis opening | Standard Deviation 16 |
| McGrath | Percentage of Glottic Opening (POGO) [%] | 91 percentage of glottis opening | Standard Deviation 11 |
Primary
Time to Obtain Glottis Visualization (Seconds)
It is the time (seconds) following initial insertion of laryngoscope blade to obtain a glottic view. Start of intubation procedure to Glottic view (the opening between the vocal cords at the upper part of the larynx) visualization comparison between the four devices in patients undergoing bariatric surgery
Time frame: up to 1 minute
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Direct Macintosh Laryngoscopy | Time to Obtain Glottis Visualization (Seconds) | 20 Seconds | Standard Deviation 28 |
| Video-Mac | Time to Obtain Glottis Visualization (Seconds) | 9 Seconds | Standard Deviation 8 |
| GlideScope | Time to Obtain Glottis Visualization (Seconds) | 12 Seconds | Standard Deviation 9 |
| McGrath | Time to Obtain Glottis Visualization (Seconds) | 10 Seconds | Standard Deviation 9 |