Clinical Study
The Stable Airway Management (SAM) device was evaluated in a randomized controlled clinical study to assess its safety and performance during Monitored Anesthesia Care (MAC) procedures.
Study Site
Virginia Commonwealth University Medical Center
Quaternary Care Center – Richmond, Virginia
Regulatory Status
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FDA Class I medical device
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Designated Non-Significant Risk (NSR)
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Investigational Device Exemption (IDE) in place
ClinicalTrials.gov Identifier:
NCT05087979
Complete protocol and registry:
Study Design
- Prospective, randomized, single-blinded study
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40 adult patients undergoing MAC:
– 20 Standard of Care (SOC)
– 20 SAM -
Median age: 61 years
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Median BMI: approximately 29 kg/m²
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Patients were followed intraoperatively and surveyed three days post-operatively.
Study Objectives
- Determine whether use of SAM reduces the need for provider airway adjustments compared to Standard of Care.
- Evaluate whether patient BMI moderates device performance.
- Assess safety by measuring conversion from MAC to general anesthesia.
Primary Outcomes
Airway Manipulation
SAM use was not associated with a statistically significant increase in airway manipulation compared to SOC.
Conversion to General Anesthesia
No association was observed between SAM use and increased conversion from MAC to general anesthesia.
Patient Safety & Comfort
No reports of post-operative neck or jaw pain or stiffness were recorded in the SAM cohort.
BMI Considerations
The device demonstrated applicability across the studied BMI range without restriction.
Clinical Context
Monitored Anesthesia Care avoids routine intubation but introduces variability in airway positioning. In expanding Non-Operating Room Anesthesia (NORA) environments, maintaining airway patency remains a central safety priority.
The study findings support that SAM can be used during MAC without increasing procedural risk relative to Standard of Care.
Regulatory Status
& Clinical Adoption
Regulatory & Manufacturing Profile
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FDA Class I medical device
-
Non-Significant Risk (NSR) designation
-
Investigational Device Exemption (IDE) in place
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Patent protected (U.S. Patents 11,523,961 and 11,806,285)
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100% Manufactured in the United States
Manufactured, assembled, and packaged in Waynesboro, Virginia using medical-grade materials.
Designed for Evaluation
SAM is intended for review and evaluation by:
- Anesthesiologists and CRNAs
- Hospital administrators
- Healthcare Technology Management (HTM)
- Procurement and supply leadership
We're Here Whenever You Need Us
info@stableairway.com
(123) 456 7890
Stable Airway Management
1234 Any Rd.
Any Town, IL 60098
Our team is available to support healthcare professionals, administrators, and procurement teams in evaluating the Stable Airway Management (SAM) device.
We are ready to provide clinical information, discuss implementation, and arrange product demonstrations tailored to your institution’s needs. Please contact us to learn more or to schedule a conversation with our team.
