An interventional study of Stable airway management (SAM) device in Anesthesia, sponsored by Virginia Commonwealth University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-08.
Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Prevention
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.
Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.
Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
An investigational device will be used to hold patient's head and airway in a stable position.
Device: Stable airway management (SAM) device
Pillows and towels will be used to hold patient's head and airway in a stable position.
SAM is positioning device that will maintain patient's head, neck, and therefore their airway in the correct position during their procedure.
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.
Time frame: 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
Time frame: Up to 6 hours
| Milestone | Intervention | Standard of Care |
|---|---|---|
| Started | 20 | 20 |
| Completed | 19 | 20 |
| Not completed | 1 | 0 |
| Withdrew: Converted to general anesthesia | 1 | 0 |
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.
| Number of airway manipulations | Intervention | Standard of Care |
|---|---|---|
| Total Apneic Events /Total Number Requiring Airway Manipulation | 2 (0 to 10) | 1 (0 to 11) |
Number of participants converted from MAC to general anesthesia for airway-related complications
| participants | Intervention | Standard of Care |
|---|---|---|
| Number of Subjects Converted From MAC to General Anesthesia | 1 | 0 |
Collected over Up to 3-4 days post procedure. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Standard of Care | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Continuous(years) | Intervention | Standard of Care | Total |
|---|---|---|---|
| Median | 61 (26 to 78) | 61 (38 to 84) | 61 (26 to 84) |
| Sex: Female, Male(Participants) | Intervention | Standard of Care | Total |
|---|---|---|---|
| Female | 13 | 11 | 24 |
| Male | 7 | 9 | 16 |
| Race and Ethnicity Not Collected(Participants) | Intervention | Standard of Care | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Intervention | Standard of Care | Total |
|---|---|---|---|
| United States | 20 | 20 | 40 |
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Plan to share: No
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Virginia Commonwealth University