Use of Stable Airway Management Device in Monitored Anesthesia Care

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-28

Study Completion Date

2022-09-29

Brief Summary

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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).

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Detailed Description

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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

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Stable airway management (SAM) device

Intervention Type DEVICE

SAM is positioning device that will maintain patient's head, neck, and therefore their airway in the correct position during their procedure.

Standard of care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No