Use of Stable Airway Management Device in Monitored Anesthesia Care

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Anesthesia

Treatments: Device: Stable airway management (SAM) device

Study type: Interventional

Funder types: Other

Identifiers

NCT05087979

HM20022338

Details and patient eligibility

About

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).

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Device: Stable airway management (SAM) device

Standard of care

No Intervention group

Description:

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