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| Name | Class |
|---|---|
| University of Iowa | OTHER |
| The University of Texas Health Science Center, Houston | OTHER |
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This study evaluates success rates of tracheal intubation (passing a breathing tube)for patients who may be more challenging to intubate while utilizing one of two devices that facilitate placement of the tube with video technology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C-MAC | Active Comparator | Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation |
|
| Glidescope | Active Comparator | Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C-MAC | Device | C-MAC arm |
| |
| Glidescope |
| Measure | Description | Time Frame |
|---|---|---|
| Intubation Success Rate | Success rate is defined as a single blade insertion with successful tracheal tube placement confirmed by return of end-tidal carbon dioxide | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Intubation Time | Intubation time is defined as the time from blade insertion to first return of end-tidal carbon dioxide | 1 week |
| Graded Score of Laryngeal View Achieved | Laryngeal view is defined by the modified Cormack and Lehane scale (1-4) and is assessed by the clinician and the study team. Grade 1 is considered to be a good view while grade 4 is considered to be a poor view. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22261795 | Background | Aziz MF, Dillman D, Fu R, Brambrink AM. Comparative effectiveness of the C-MAC video laryngoscope versus direct laryngoscopy in the setting of the predicted difficult airway. Anesthesiology. 2012 Mar;116(3):629-36. doi: 10.1097/ALN.0b013e318246ea34. |
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| ID | Title | Description |
|---|---|---|
| FG000 | C-MAC | Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation C-MAC: C-MAC arm |
| FG001 | Glidescope | Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation Glidescope: Glidescope arm |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | C-MAC | Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation C-MAC: C-MAC arm |
| BG001 | Glidescope | Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation Glidescope: Glidescope arm |
| 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 Success Rate | Success rate is defined as a single blade insertion with successful tracheal tube placement confirmed by return of end-tidal carbon dioxide | Posted | Number | participants | 1 week |
|
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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 | C-MAC | Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation C-MAC: C-MAC arm |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pharyngeal injury | Surgical and medical procedures | Systematic Assessment | pharyngeal injury |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Aziz, MD | Oregon Health & Science University | 503-494-5581 | azizm@ohsu.edu |
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| Device |
Glidescope arm |
|
| 1 week |
| Number of Particpants Requiring Adjuncts to Assist Intubation | The need for use of a gum-elastic bougie or external laryngeal manipulation to facilitate tube placement will be measured by the study team. | 1 week |
| Number of Participants With Observed Complications | Patients will be examined for evidence of mucosal or dental injury upon intervention. Patients will be asked if they have a sore throat in the recovery room, and their medical record will be reviewed to determine if any other airway related complications were observed by the clinical team including the need for reintubation or steroid administration to reduce swelling. | 1 week |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Units | Counts |
|---|
| Participants |
|
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| Secondary | Intubation Time | Intubation time is defined as the time from blade insertion to first return of end-tidal carbon dioxide | Posted | Mean | Inter-Quartile Range | seconds | 1 week |
|
|
|
| Secondary | Graded Score of Laryngeal View Achieved | Laryngeal view is defined by the modified Cormack and Lehane scale (1-4) and is assessed by the clinician and the study team. Grade 1 is considered to be a good view while grade 4 is considered to be a poor view. | Cormack-Lehane grade | Posted | Number | participants | 1 week | grade | grade |
|
|
|
| Secondary | Number of Particpants Requiring Adjuncts to Assist Intubation | The need for use of a gum-elastic bougie or external laryngeal manipulation to facilitate tube placement will be measured by the study team. | Posted | Count of Participants | Participants | 1 week |
|
|
|
| Secondary | Number of Participants With Observed Complications | Patients will be examined for evidence of mucosal or dental injury upon intervention. Patients will be asked if they have a sore throat in the recovery room, and their medical record will be reviewed to determine if any other airway related complications were observed by the clinical team including the need for reintubation or steroid administration to reduce swelling. | Posted | Count of Participants | Participants | 1 week |
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|
|
| 0 |
| 548 |
| 4 |
| 548 |
| EG001 | Glidescope | Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation Glidescope: Glidescope arm | 0 | 552 | 7 | 552 |
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| Grade 3 |
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| Grade 4 |
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