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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Video-Mac | Experimental | Video-Mac device used during intubation procedure |
|
| GlideScope | Experimental | GlideScope device used during intubation procedure |
|
| McGrath | Experimental | McGrath device used during intubation procedure |
|
| Direct Macintosh Laryngoscopy | Active Comparator | Direct Macintosh Laryngoscopy (DL) used during intubation procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| McGrath | Device | Intubation with the McGrath device |
| |
| GlideScope |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 3 minutes |
| 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 | up to 1 minute |
| 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. | up to 1 minute |
| 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 | Up to 1 minute |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roya Yumul, MD, PhD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Video-Mac | Video-Mac device |
| FG001 | GlideScope | GlideScope device |
| FG002 | McGrath | MacGrath |
| FG003 | Direct Macintosh Laryngoscopy | Direct Macintosh Laryngoscopy (DL) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Obese patients (ASA II-III). In the Direct Macintosh group there is one more participant included, this is due that the last participant declined to complete with the last assessment.
Later changed his mind and completed the study (In that time we had enrolled another subject so we decided to use the data of both participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Direct Macintosh Laryngoscopy | Direct Macintosh Laryngoscope device |
| BG001 | Video-Mac | Video-Mac device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Times following initial insertion of laryngoscope blade: to obtain glottic view (sec) to placement of tracheal tube (sec) to confirm with CO2 waveform (sec) | Posted | Mean | Standard Deviation | Seconds | up to 3 minutes |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Video-Mac | Video-Mac device used during intubation procedure McGrath: McGrath will be compared with: Direct Macintosh Laryngoscopy Video-Mac GlideScope GlideScope: GlideScope will be compared with: Direct Macintosh Laryngoscopy Video-Mac and McGrath Direct Macintosh Laryngoscopy: Direct Macintosh Laryngoscopy will be compared with: GlideScope Video-Mac and McGrath |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roya Yumul, M.D., Ph.D. | Department of Anesthesiology at Cedars-Sinai Medical Center in Los Angeles | 310-423-5841 | (Roya.Yumul@cshs.org) |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Device |
Intubation with the GlideScope device |
|
| Direct Macintosh Laryngoscopy | Device | Intubation with Direct Macintosh Laryngoscope |
|
| Video-Mac | Device | Intubation with the Video-Mac device |
|
| BG002 |
| GlideScope |
GlideScope device |
| BG003 | McGrath | MacGrath device |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| OG002 | GlideScope | GlideScope device |
| OG003 | McGrath | MacGrath device |
|
|
| 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 | Posted | Mean | Standard Deviation | Seconds | up to 1 minute |
|
|
|
| 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. | Posted | Mean | Standard Deviation | percentage of glottis opening | up to 1 minute |
|
|
|
| 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 | Cormack Lehane score (grade:1/2/3/4 [n]) | Posted | Number | participants | Up to 1 minute |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | GlideScope | GlideScope device used during intubation procedure McGrath: McGrath will be compared with: Direct Macintosh Laryngoscopy Video-Mac GlideScope Direct Macintosh Laryngoscopy: Direct Macintosh Laryngoscopy will be compared with: GlideScope Video-Mac and McGrath Video-Mac: Video-Mac will be compared with: Direct Macintosh Laryngoscopy GlideScope and McGrath | 0 | 30 | 0 | 30 |
| EG002 | McGrath | McGrath device used during intubation procedure GlideScope: GlideScope will be compared with: Direct Macintosh Laryngoscopy Video-Mac and McGrath Direct Macintosh Laryngoscopy: Direct Macintosh Laryngoscopy will be compared with: GlideScope Video-Mac and McGrath Video-Mac: Video-Mac will be compared with: Direct Macintosh Laryngoscopy GlideScope and McGrath | 0 | 30 | 0 | 30 |
| EG003 | Direct Macintosh Laryngoscopy | Direct Macintosh Laryngoscopy (DL) used during intubation procedure McGrath: McGrath will be compared with: Direct Macintosh Laryngoscopy Video-Mac GlideScope GlideScope: GlideScope will be compared with: Direct Macintosh Laryngoscopy Video-Mac and McGrath Video-Mac: Video-Mac will be compared with: Direct Macintosh Laryngoscopy GlideScope and McGrath | 0 | 31 | 0 | 31 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|