Use of Stable Airway Management Device in Monitored Anesthesia Care

April 5, 2024 updated by: Virginia Commonwealth University
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 6 hours
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
Up to 6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Investigators

  • Principal Investigator: Visnal Yajnik, MD, Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2022

Primary Completion (Actual)

September 29, 2022

Study Completion (Actual)

September 29, 2022

Study Registration Dates

First Submitted

October 8, 2021

First Submitted That Met QC Criteria

October 8, 2021

First Posted (Actual)

October 21, 2021

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HM20022338

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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