N/A
N=40
Use of Stable Airway Management Device in Monitored Anesthesia Care
Anesthesia
Bottom Line
View on ClinicalTrials.gov: NCT05087979 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Total Apneic Events /Total Number Requiring Airway Manipulation — 2; 1 Number of airway manipulations
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Stable airway management (SAM) device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Apneic Events /Total Number Requiring Airway Manipulation |
2; 1 | — |
| PRIMARY Number of Subjects Converted From MAC to General Anesthesia |
1; 0 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Patients undergoing MAC anesthesia in the supine position
- Patients able to give informed consent
Exclusion Criteria
- Age 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
Data sourced from ClinicalTrials.gov (NCT05087979). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.