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Completed

NCT Number: NCT05087979

Use of Stable Airway Management Device in Monitored Anesthesia Care

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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Key information

Conditions

Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stable airway management (SAM) device

Device

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

Primary outcomes

  1. Total Apneic Events /Total Number Requiring Airway Manipulation

    Time frame: 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.

  2. Number of Subjects Converted From MAC to General Anesthesia

    Time frame: Up to 6 hours

    Number of participants converted from MAC to general anesthesia for airway-related complications

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 21, 2021
Registry last updated
Apr 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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