Use of Stable Airway Management Device in Monitored Anesthesia Care
1 other identifier
interventional
40
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2021
CompletedFirst Posted
Study publicly available on registry
October 21, 2021
CompletedStudy Start
First participant enrolled
July 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 29, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 29, 2022
CompletedResults Posted
Study results publicly available
April 8, 2024
CompletedApril 8, 2024
April 1, 2024
2 months
October 8, 2021
October 18, 2023
April 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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
Up to 6 hours
Study Arms (2)
Intervention
EXPERIMENTALAn investigational device will be used to hold patient's head and airway in a stable position.
Standard of care
NO INTERVENTIONPillows and towels will be used to hold patient's head and airway in a stable position.
Interventions
SAM is positioning device that will maintain patient's head, neck, and therefore their airway in the correct position during their procedure.
Eligibility Criteria
You may qualify if:
- Patients undergoing MAC anesthesia in the supine position
- Patients able to give informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Results Point of Contact
- Title
- Vishal Yajnik, MD, MS
- Organization
- Virginia Commonwealth University
Study Officials
- PRINCIPAL INVESTIGATOR
Visnal Yajnik, MD
Virginia Commonwealth University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2021
First Posted
October 21, 2021
Study Start
July 28, 2022
Primary Completion
September 29, 2022
Study Completion
September 29, 2022
Last Updated
April 8, 2024
Results First Posted
April 8, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share