Use of Stable Airway Management Device in Monitored Anesthesia Care

Not Applicable

Completed

• Conditions: Anesthesia
• Interventions: Device: Stable airway management (SAM) device

• Registration Number: NCT05087979
• Lead Sponsor: Virginia Commonwealth University

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).

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.

Study Timeline

• Study First Submitted: 2021-10-08
• Study First Submitted QC: 2021-10-08
• Study First Posted: 2021-10-21
• Study Start: 2022-07-28
• Primary Completion: 2022-09-29
• Study Completion: 2022-09-29
• Results First Submitted: 2023-10-18
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-05
• Last Update Submitted: 2024-04-05
• Results First Posted: 2024-04-08
• Last Update Posted: 2024-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Patients undergoing MAC anesthesia in the supine position
2. Patients able to give informed consent

Exclusion Criteria

1. Age < 18 years
2. Less than 88% oxygen saturation on room air
3. Non-elective procedures
4. Case duration > 180 minutes
5. Presence of a cervical spine injury, instability, or cervical spine collar
6. Patients with airway, facial, or other anatomy deemed inappropriate for SAM use by anesthesiologist
7. General anesthesia as primary anesthetic
8. Prisoners
9. Pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Stable airway management (SAM) device	An investigational device will be used to hold patient's head and airway in a stable position.

Primary Outcome Measures

Name	Time	Method
Total Apneic Events /Total Number Requiring Airway Manipulation	Up to 6 hours	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.
Number of Subjects Converted From MAC to General Anesthesia	Up to 6 hours	Number of participants converted from MAC to general anesthesia for airway-related complications

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States