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Recruiting Not applicable NCT07216573

The Continuity Study

No applicable phase (e.g. observational)
Conditions: Blood Pressure

Sponsor: Edwards Lifesciences

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Overview
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.
Who can participate
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)
Interventions
HemoSphere Vita Monitor with VitaWave or VitaWave Plus Finger Cuff Adult, and ForeSight Large Sensors
DEVICE
Locations 1
United States (1)
University of Rochester Medical Center
Rochester , New York
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.04.2026
Completion date
01.02.2027
Registry ID
NCT07216573
Source
clinicaltrials.gov
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