Anesthesia
Conditions
Keywords
monitored anesthesia care
Brief summary
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).
Detailed description
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.
Interventions
DEVICEStable 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.
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients undergoing MAC anesthesia in the supine position 2. Patients able to give informed consent
Exclusion criteria
1. Age \< 18 years 2. Less than 88% oxygen saturation on room air 3. Non-elective procedures 4. Case duration \> 180 minutes 5. Presence of a cervical spine injury, instability, or cervical spine collar 6. Patients with airway, facial, or other anatomy deemed inappropriate for SAM use by anesthesiologist 7. General anesthesia as primary anesthetic 8. Prisoners 9. Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Apneic Events /Total Number Requiring Airway Manipulation | Up to 6 hours | 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 Subjects Converted From MAC to General Anesthesia | Up to 6 hours | Number of participants converted from MAC to general anesthesia for airway-related complications |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Standard of Care Pillows and towels will be used to hold patient's head and airway in a stable position. | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Converted to general anesthesia | 1 | 0 |
Baseline characteristics
| Characteristic | Standard of Care | Total | Intervention |
|---|---|---|---|
| Age, Continuous | 61 years | 61 years | 61 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 20 participants | 40 participants | 20 participants |
| Sex: Female, Male Female | 11 Participants | 24 Participants | 13 Participants |
| Sex: Female, Male Male | 9 Participants | 16 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Number of Subjects Converted From MAC to General Anesthesia | 1 participants |
| Standard of Care | Number of Subjects Converted From MAC to General Anesthesia | 0 participants |
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.
Time frame: Up to 6 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | Total Apneic Events /Total Number Requiring Airway Manipulation | 2 Number of airway manipulations |
| Standard of Care | Total Apneic Events /Total Number Requiring Airway Manipulation | 1 Number of airway manipulations |