NCT05087979

Use of Stable Airway Management Device in Monitored Anesthesia Care

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Anesthesia

Interventions

Type	Name	Description
DEVICE	Stable airway management (SAM) device	SAM is positioning device that will maintain patient's head, neck, and therefore their airway in the correct position during their procedure.

Timeline

• Start date: 2022-07-28
• Primary completion: 2022-09-29
• Completion: 2022-09-29
• First posted: 2021-10-21
• Last updated: 2024-04-08
• Results posted: 2024-04-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study