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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
40
SAM is positioning device that will maintain patient's head, neck, and therefore their airway in the correct position during their procedure.
Virginia Commonwealth University
Richmond, Virginia, United States
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
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