Use of Stable Airway Management Device in Monitored Anesthesia Care

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Use of Stable Airway Management Device in Monitored Anesthesia Care

Conditions
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Anesthesia

Intervention / Treatment
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* Device: Stable airway management (SAM) device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing MAC anesthesia in the supine position Patients able to give informed consent Exclusion Criteria: Age < 18 years Less than 88% oxygen saturation on room air Non-elective procedures Case duration > 180 minutes Presence of a cervical spine injury, instability, or cervical spine collar Patients with airway, facial, or other anatomy deemed inappropriate for SAM use by anesthesiologist General anesthesia as primary anesthetic Prisoners Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>An investigational device will be used to hold patient's head and airway in a stable position. | Device: Stable airway management (SAM) device<br>* SAM is positioning device that will maintain patient's head, neck, and therefore their airway in the correct position during their procedure.<br>|
| No Intervention: Standard of care<br>Pillows and towels will be used to hold patient's head and airway in a stable position. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of apneic events | Number of apneic events greater than 20 seconds per 15-minute intervals. Total number of events will be reported. | Up to 6 hours | 
| Conversion to general anesthesia | Number of participants converted from MAC to general anesthesia for airway-related complications | Up to 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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monitored anesthesia care