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The purpose of this study is to evaluate whether tracheal intubation with the CMAC device decreases the time required for intubation as compared to intubation with the fiberoptic bronchoscope in patients with an unstable cervical spine. Both the CMAC device and the fiberoptic bronchoscope are currently commonly used in standard of care practices in the intubation of patients with cervical spine injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CMAC Device | Other | CMAC Intubating device time to achieve successful tracheal intubation. |
|
| Fiberoptic bronchoscope | Active Comparator | Fiberoptic bronchoscope Intubating device time to achieve successful tracheal intubation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fiberoptic bronchoscope | Device | Fiberoptic bronchoscope device |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Intubation Time (Seconds) | Times (seconds) following initial insertion of laryngoscope blade to placement of tracheal tube | 3 minutes |
| Time to Confirm the Placement of the Tracheal Tube | It is the time (in seconds) following initial insertion of laryngoscope blade to confirm with CO2 waveform | up tp 3 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Obtain Glottis Visualization (Seconds) | Time to Obtain Glottis Visualization (Seconds): View of the glottis during the beginning of the intubation procedure. (approximately 1 minute) Glottic (the opening between the vocal cords at the upper part of the larynx) visualization comparison between the two devices in patients with an unstable cervical spine. | 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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| ID | Title | Description |
|---|---|---|
| FG000 | CMAC Device | CMAC CMAC: CMAC Device |
| FG001 | Fiberoptic Bronchoscope | Fiberoptic bronchoscope device: the flexible fiberoptic scope (FFS) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CMAC Device | CMAC CMAC: CMAC Device |
| BG001 | Fiberoptic Bronchoscope | Fiberoptic bronchoscope Fiberoptic bronchoscope: Fiberoptic bronchoscope 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Time to Obtain Glottis Visualization (Seconds) | Time to Obtain Glottis Visualization (Seconds): View of the glottis during the beginning of the intubation procedure. (approximately 1 minute) Glottic (the opening between the vocal cords at the upper part of the larynx) visualization comparison between the two devices in patients with an unstable cervical spine. | Time to Obtain Glottis Visualization (Seconds) Glottic visualization during the beginning of the intubation procedure. | Posted | Mean | Standard Deviation | Seconds | 1 minute |
|
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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 Device | CMAC CMAC: CMAC Device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roya Yumul, M.D., Ph.D. | Department of Anesthesiology, Cedars-Sinai Medical Center | 310-423-5841 | (Roya.Yumul@cshs.org) |
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| CMAC |
| Device |
CMAC Device |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Intubation Time (Seconds) | Times (seconds) following initial insertion of laryngoscope blade to placement of tracheal tube | Posted | Mean | Standard Deviation | Seconds | 3 minutes |
|
|
|
| Primary | Time to Confirm the Placement of the Tracheal Tube | It is the time (in seconds) following initial insertion of laryngoscope blade to confirm with CO2 waveform | Posted | Mean | Standard Deviation | Seconds | up tp 3 minutes |
|
|
|
| 0 |
| 70 |
| 0 |
| 70 |
| EG001 | Flexible Fiberoptic Scope (FFS) | the flexible fiberoptic scope (FFS) the flexible fiberoptic scope (FFS) : the flexible fiberoptic scope (FFS) | 0 | 70 | 0 | 70 |
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