Blood Pressure
Conditions
Brief 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.
Interventions
DEVICEHemoSphere 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
Sponsors
Becton, Dickinson and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Contacts
CONTACTCristina Johnson
Outcome results
None listed