Use of Stable Airway Management Device in Monitored Anesthesia Care

Sponsor

Virginia Commonwealth University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05087979

Collaborator

(none)

Enrollment

Location

Arms

4.1

Anticipated Duration (Months)

9.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Device: Stable airway management (SAM) device	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Use of Stable Airway Management Device in Monitored Anesthesia Care

Actual Study Start Date :

Jul 28, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention An investigational device will be used to hold patient's head and airway in a stable position.	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.
No Intervention: Standard of care Pillows and towels will be used to hold patient's head and airway in a stable position.

Arm

Intervention/Treatment

Experimental: Intervention

An investigational device will be used to hold patient's head and airway in a stable position.

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.

No Intervention: Standard of care

Pillows and towels will be used to hold patient's head and airway in a stable position.

Outcome Measures

Primary Outcome Measures

Number of apneic events [Up to 6 hours]
Number of apneic events greater than 20 seconds per 15-minute intervals. Total number of events will be reported.
Conversion to general anesthesia [Up to 6 hours]
Number of participants converted from MAC to general anesthesia for airway-related complications

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
Pregnant women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Virginia Commonwealth University	Richmond	Virginia	United States	23298

Sponsors and Collaborators

Virginia Commonwealth University

Investigators

Principal Investigator: Visnal Yajnik, MD, Virginia Commonwealth University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Virginia Commonwealth University

ClinicalTrials.gov Identifier:

NCT05087979

Other Study ID Numbers:

HM20022338

First Posted:

Oct 21, 2021

Last Update Posted:

Aug 4, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Virginia Commonwealth University

monitored anesthesia care

Study Results

No Results Posted as of Aug 4, 2022