Use of Stable Airway Management Device in Monitored Anesthesia Care

Anesthesia Clinical Trial

Official title:

Use of Stable Airway Management Device in Monitored Anesthesia Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05087979
• Other study ID #: HM20022338
• Status: Completed
• Phase: N/A
• Start date: July 28, 2022
• Est. completion date: September 29, 2022

Study information

• Verified date: April 2024
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 29, 2022
• Est. primary completion date: September 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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