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This study aims to evaluate the utility of a video assisted device for intubation (placement of a breathing tube) during surgery. This study specifically aims to compare a video assisted intubation with the CMAC laryngoscope to conventional devices in the setting of intubations predicted to be difficult.
Patients will be specifically screened for predictors by history and physical exam of potential airway difficulty. The role of video laryngoscopy in airways predicted to be difficult is poorly defined. This study aims to recognize if video laryngoscopy is more useful than conventional laryngoscopy as a first attempt for those with anticipated difficulty.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CMAC Video laryngoscope | Active Comparator | Subjects will have their intubation attempted first with the CMAC video laryngoscope |
|
| Macintosh blade | Active Comparator | Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CMAC video laryngoscope | Device | Intubation utilizing the assistance of video enhancement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure of Intubation Success | Success was measured by confirmed tracheal tube placement with one attempt. Any removal of the laryngoscope blade constituted a failure | During each intubation in a 14 month period |
| Measure | Description | Time Frame |
|---|---|---|
| Intubation Time | Time was measured as the duration of laryngoscopy defined by blade insertion to tracheal tube cuff inflation | During laryngoscopy procedure |
| Number of Participants Intubated With a Rescue Device |
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Inclusion Criteria:
Adult patients presenting for elective surgery who are fasted and who have one of the following difficult airway predictors:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Aziz, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19233881 | Background | Jungbauer A, Schumann M, Brunkhorst V, Borgers A, Groeben H. Expected difficult tracheal intubation: a prospective comparison of direct laryngoscopy and video laryngoscopy in 200 patients. Br J Anaesth. 2009 Apr;102(4):546-50. doi: 10.1093/bja/aep013. Epub 2009 Feb 20. |
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4 exclusions were noted for failure to follow the randomization
Patients were recruited at OHSU OR and procedure rooms. 300 patients were enrolled in the study from 10/09-12/10
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| ID | Title | Description |
|---|---|---|
| FG000 | CMAC Video Laryngoscope | Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion |
| FG001 | Macintosh Blade | Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | CMAC Video Laryngoscope | Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion |
| BG001 | Macintosh Blade |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Measure of Intubation Success | Success was measured by confirmed tracheal tube placement with one attempt. Any removal of the laryngoscope blade constituted a failure | 4 patients of the 300 were excluded because the randomization was not followed due to unavailability of equipment or provider preference to remove patient from study | Posted | Feb 2011 | Number | 95% Confidence Interval | Participants | During each intubation in a 14 month period |
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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 | CMAC Video Laryngoscope | Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Aziz | Oregon Health & Science University | 503-494-5581 | azizm@ohsu.edu |
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| Macintosh laryngoscope | Device | Patients will be intubated utilizing either a Macintosh 3 or Macintosh 4 designed blade |
|
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| 1 year |
| Number of Participants With Complications | 1 year |
| Number of Participants With a Laryngeal View Grade of 1 or 2 vs. 3 or 4. | Grade 1= full view of the glottis achieved Grade 2= partial view of the glottis achieved Grade 3= only the epiglottis visualized Grade 4= no laryngeal view achieved | 1 year |
| Number of Particpants Requiring Adjuncts to Assist Intubation | 1 year |
Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion
|
|
| Secondary | Intubation Time | Time was measured as the duration of laryngoscopy defined by blade insertion to tracheal tube cuff inflation | time | Posted | Mean | 90% Confidence Interval | seconds | During laryngoscopy procedure |
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| Secondary | Number of Participants Intubated With a Rescue Device | Posted | Number | participants | 1 year |
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| Secondary | Number of Participants With Complications | Posted | Count of Participants | Participants | 1 year |
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| Secondary | Number of Participants With a Laryngeal View Grade of 1 or 2 vs. 3 or 4. | Grade 1= full view of the glottis achieved Grade 2= partial view of the glottis achieved Grade 3= only the epiglottis visualized Grade 4= no laryngeal view achieved | Posted | Count of Participants | Participants | 1 year |
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| Secondary | Number of Particpants Requiring Adjuncts to Assist Intubation | Use of bougie or external manipulation | Posted | Count of Participants | Participants | 1 year |
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| 0 |
| 150 |
| 0 |
| 150 |
| EG001 | Macintosh Blade | Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion | 0 | 150 | 0 | 150 |
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| Grade 3 view achieved |
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| Grade 4 view achieved |
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