CompletedNot Applicable

Use of Stable Airway Management Device in Monitored Anesthesia Care

United States40 participantsStarted 2022-07-28

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Total Apneic Events /Total Number Requiring Airway Manipulation

Timeframe: Up to 6 hours

Number of Subjects Converted From MAC to General Anesthesia

Timeframe: Up to 6 hours

Trial details

NCT IDNCT05087979

SponsorVirginia Commonwealth University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-29

Results submitted2023-10-18

View on ClinicalTrials.gov More Anesthesia trials