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The aim of this study is to determine if the Stable Airway Management device (SAM) is safe in maintaining the airway in a stable, non-obstructing position during anesthetic cases requiring monitored anesthesia care (MAC).
Patients undergoing monitored anesthesia care as part of a procedure will be invited to participate in the study.
The stable airway management (SAM) device is an investigational device used to hold patient's head and airway in a stable position during a MAC procedure. An investigational device means it has not been approved by the U. S. Food and Drug Administration (FDA). In this study, the SAM will be compared to the standard of anesthesia care which consists of supporting patient's head, neck, and shoulders with pillows and towels when placing them in the correct position for the procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | An investigational device will be used to hold patient's head and airway in a stable position. |
|
| Standard of care | No Intervention | Pillows and towels will be used to hold patient's head and airway in a stable position. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stable airway management (SAM) device | Device | SAM is positioning device that will maintain patient's head, neck, and therefore their airway in the correct position during their procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Apneic Events /Total Number Requiring Airway Manipulation | total number of apneic events greater than 20 seconds per 15-minute intervals, requiring airway manipulation - The median value of airway manipulations will be reported for each arm, along with the range of manipulations (low-high) for each study arm will be reported. | Up to 6 hours |
| Number of Subjects Converted From MAC to General Anesthesia | Number of participants converted from MAC to general anesthesia for airway-related complications | Up to 6 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Visnal Yajnik, MD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | An investigational device will be used to hold patient's head and airway in a stable position. Stable airway management (SAM) device: SAM is positioning device that will maintain patient's head, neck, and therefore their airway in the correct position during their procedure. |
| FG001 | Standard of Care | Pillows and towels will be used to hold patient's head and airway in a stable position. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | An investigational device will be used to hold patient's head and airway in a stable position. Stable airway management (SAM) device: SAM is positioning device that will maintain patient's head, neck, and therefore their airway in the correct position during their procedure. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Total Apneic Events /Total Number Requiring Airway Manipulation | total number of apneic events greater than 20 seconds per 15-minute intervals, requiring airway manipulation - The median value of airway manipulations will be reported for each arm, along with the range of manipulations (low-high) for each study arm will be reported. | Posted | Median | Full Range | Number of airway manipulations | Up to 6 hours |
|
Up to 3-4 days post procedure
Post-procedure safety monitoring: patient self report. Patients rated their level of discomfort in the jaw, neck, and head from the start of the procedure up until day 3 of post-procedure
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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 | Intervention | An investigational device will be used to hold patient's head and airway in a stable position. Stable airway management (SAM) device: SAM is positioning device that will maintain patient's head, neck, and therefore their airway in the correct position during their procedure. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vishal Yajnik, MD, MS | Virginia Commonwealth University | 804-663-3519 | vishal.yajnik@vcuhealth.org |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 4, 2021 | Oct 18, 2023 | Prot_000.pdf |
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| Standard of Care |
Pillows and towels will be used to hold patient's head and airway in a stable position. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Pillows and towels will be used to hold patient's head and airway in a stable position.
|
|
| Primary | Number of Subjects Converted From MAC to General Anesthesia | Number of participants converted from MAC to general anesthesia for airway-related complications | Posted | Number | participants | Up to 6 hours |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Standard of Care | Pillows and towels will be used to hold patient's head and airway in a stable position. | 0 | 20 | 0 | 20 | 0 | 20 |
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