Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
188 participants
INTERVENTIONAL
2025-11-30
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
OTHER
NONE
Study Groups
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Cohort 1 - Standard of Care
Study device data are blinded to the provider
HemoSphere Vita Monitor, VitaWave or VitaWave Plus Finger Cuff Adult, ForeSight Large Sensors
Devices are applied for monitoring throughout the duration of the procedure.
Cohort 2 - Standard of Care with cNIBP Monitoring
Study device continuous non-invasive blood pressure data are unblinded to the provider
HemoSphere Vita Monitor, VitaWave or VitaWave Plus Finger Cuff Adult, ForeSight Large Sensors
Devices are applied for monitoring throughout the duration of the procedure.
Interventions
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HemoSphere Vita Monitor, VitaWave or VitaWave Plus Finger Cuff Adult, ForeSight Large Sensors
Devices are applied for monitoring throughout the duration of the procedure.
Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years
3. ASA Physical Status ≥ 2
4. Scheduled for elective noncardiac surgery with intermittent arterial blood pressure monitoring using oscillometric arm cuff
Exclusion Criteria
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)
18 Years
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Responsible Party
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Locations
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University of Rochester Medical Center
Rochester, New York, United States
Countries
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Central Contacts
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Other Identifiers
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2025-06
Identifier Type: -
Identifier Source: org_study_id
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