HemoSphere Vita Monitor with VitaWave or VitaWave Plus Finger Cuff Adult, and ForeSight Large Sensors
HemoSphere Vita Monitor with VitaWave or VitaWave Plus Finger Cuff Adult, and ForeSight Large Sensors: Devices are applied for monitoring throughout the duration of the procedure
Study summary
A before and after interventional cohort study comparing intermittent blood pressure measurement using the oscillometric arm cuff to continuous noninvasive blood pressure (cNIBP) measurement using the VitaWave finger cuffs in subjects undergoing elective surgery in an outpatient setting.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Signed informed consent
2. Age ≥ 18 years
3. American Society of Anesthesiologists (ASA) Physical Status ≥ 2
4. Scheduled for elective noncardiac surgery with intermittent arterial blood pressure monitoring using oscillometric arm cuff
Exclusion Criteria:
1. Patient who is known to be pregnant
2. Patient with existing or planned arterial pressure catheter
3. Patient in whom systolic arterial pressure differs by more than 20 mmHg between the right and left arms
4. Inability to place oscillometric cuff on the subject's upper extremity
5. Extreme contraction of the smooth muscle in the arteries and arterioles of the lower arm and hand, such as may be present in patients with Raynaud's disease
6. Finger or hand deformity that prevents proper placement of finger cuff by visual inspection
7. Inability to place finger cuffs due to subject anatomy, condition, or obstructive paraphernalia (such as false nails)
Primary outcome measure(s)
Percentage of adult patients undergoing elective noncardiac surgery in the outpatient setting who experience hypotension, defined as a mean arterial pressure (MAP) < 65 mmHg, for a total duration of at least 5 minutes. — Through Study Completion, approximately 12 months
Trial sites (1)
Facility
City
Region
Status
University of Rochester Medical Center
Rochester
New York
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.