AnesthesiaNCT05087979
Use of Stable Airway Management Device in Monitored Anesthesia Care
A study testing Stable airway management (SAM) device in people with Anesthesia, run by Virginia Commonwealth University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- Stable airway management (SAM) device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2022to 29 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing MAC anesthesia in the supine position
- Patients able to give informed consent
Who cannot join
- 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
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- General anesthesia as primary anesthetic
- Prisoners
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
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).
Read the 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.
- Conditions
- Anesthesia
- Being tested
- Stable airway management (SAM) device
- Keywords
- monitored anesthesia care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stable airway management (SAM) deviceDevice
SAM is positioning device that will maintain patient's head, neck, and therefore their airway in the correct position during their procedure.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | An investigational device will be used to hold patient's head and airway in a stable position. Receives: Device: Stable airway management (SAM) device |
| Standard of care | No intervention | Pillows and towels will be used to hold patient's head and airway in a stable position. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Apneic Events /Total Number Requiring Airway Manipulation
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.
Measured: Up to 6 hours
Number of Subjects Converted From MAC to General Anesthesia
Number of participants converted from MAC to general anesthesia for airway-related complications
Measured: Up to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start28 Jul 2022
- Primary completion29 Sep 2022
- Study completion29 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Visnal Yajnik, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087979
- Sponsor's protocol ID
- HM20022338
- Status last verified
- Apr 2024
- First submitted
- 8 Oct 2021
- Last updated
- 8 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Stable Airway Management Device in Monitored Anesthesia Care
- ClinicalTrials.gov ID
- NCT05087979
- Acronym / sponsor ID
- HM20022338
- Conditions
- Anesthesia
- Keywords
- monitored anesthesia care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 28 Jul 2022 (actual)
- Primary completion
- 29 Sep 2022 (actual)
- Study completion
- 29 Sep 2022 (actual)
- First posted
- 21 Oct 2021 (actual)
- Results
- Posted 8 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Stable airway management (SAM) deviceAn investigational device will be used to hold patient's head and airway in a stable position. |
| Standard of care | No intervention | –Pillows and towels will be used to hold patient's head and airway in a stable position. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing MAC anesthesia in the supine position
- Patients able to give informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stable airway management (SAM) deviceSAM is positioning device that will maintain patient's head, neck, and therefore their airway in the correct position during their procedure. | Device | Intervention |
Primary outcome
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.
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Visnal Yajnik, MD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stable airway management (SAM) device in people with Anesthesia, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Apneic Events /Total Number Requiring Airway Manipulation (time frame: Up to 6 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.