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NCT05087979

Use of Stable Airway Management Device in Monitored Anesthesia Care

Completed NA Results posted Last updated 8 April 2024
What this trial tests

NA trial testing Stable airway management (SAM) device in Anesthesia in 40 participants. Completed in 29 September 2022.

Timeline
28 July 2022
Primary endpoint
29 September 2022
29 September 2022

Quick facts

Lead sponsorVirginia Commonwealth University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment40
Start date28 July 2022
Primary completion29 September 2022
Estimated completion29 September 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Virginia Commonwealth University

Who can join

18 and older, any sex, with Anesthesia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Total Apneic Events /Total Number Requiring Airway Manipulation Primary · 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.

GroupValue95% CI
Intervention20 – 10
Standard of Care10 – 11
Number of Subjects Converted From MAC to General Anesthesia Primary · Up to 6 hours

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

GroupValue95% CI
Intervention1
Standard of Care0

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Anesthesia

Currently open trials in the same condition.

Other Virginia Commonwealth University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05087979.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing