Trial Outcomes & Findings for Use of Stable Airway Management Device in Monitored Anesthesia Care (NCT NCT05087979)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

Up to 6 hours

Results posted on

2024-04-08

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention An investigational device will be used to hold patient's head and airway in a stable position. 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.	Standard of Care Pillows and towels will be used to hold patient's head and airway in a stable position.
Overall Study STARTED	20	20
Overall Study COMPLETED	19	20
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention An investigational device will be used to hold patient's head and airway in a stable position. 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.	Standard of Care Pillows and towels will be used to hold patient's head and airway in a stable position.
Overall Study Converted to general anesthesia	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=20 Participants An investigational device will be used to hold patient's head and airway in a stable position. 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.	Standard of Care n=20 Participants Pillows and towels will be used to hold patient's head and airway in a stable position.	Total n=40 Participants Total of all reporting groups
Age, Continuous	61 years n=20 Participants	61 years n=20 Participants	61 years n=40 Participants
Sex: Female, Male Female	13 Participants n=20 Participants	11 Participants n=20 Participants	24 Participants n=40 Participants
Sex: Female, Male Male	7 Participants n=20 Participants	9 Participants n=20 Participants	16 Participants n=40 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	20 participants n=20 Participants	20 participants n=20 Participants	40 participants n=40 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=19 Participants An investigational device will be used to hold patient's head and airway in a stable position. 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.	Standard of Care n=20 Participants Pillows and towels will be used to hold patient's head and airway in a stable position.
Total Apneic Events /Total Number Requiring Airway Manipulation	2 Number of airway manipulations Interval 0.0 to 10.0	1 Number of airway manipulations Interval 0.0 to 11.0

PRIMARY outcome

Timeframe: Up to 6 hours

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

Outcome measures

Outcome measures
Measure	Intervention n=19 Participants An investigational device will be used to hold patient's head and airway in a stable position. 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.	Standard of Care n=20 Participants Pillows and towels will be used to hold patient's head and airway in a stable position.
Number of Subjects Converted From MAC to General Anesthesia	1 participants	0 participants

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vishal Yajnik, MD, MS

Virginia Commonwealth University

Phone: 804-663-3519

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place