Continuous finger-cuff versus intermittent arm-cuff blood pressure monitoring during outpatient surgery

Continuous Blood Pressure Monitoring During Outpatient Surgery

This test tries continuous VitaWave finger‑cuff blood pressure monitoring against standard arm cuff readings in adults having elective noncardiac outpatient surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 188 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Edwards Lifesciences (industry)
• Locations: 1 site (Rochester, New York)
• Trial ID: NCT07216573 on ClinicalTrials.gov

What this trial studies

This before-and-after interventional cohort compares intermittent oscillometric arm cuff measurements to continuous noninvasive blood pressure (cNIBP) recorded with VitaWave finger cuffs and the HemoSphere Vita Monitor during elective noncardiac outpatient surgeries. Adult patients (≥18 years) with ASA physical status ≥2 who provide consent and require standard arm cuff monitoring will have finger-cuff cNIBP recorded concurrently during their procedures. Patients with pregnancy, existing arterial catheter, large inter-arm systolic differences, inability to place cuffs, Raynaud's disease, or finger/hand anatomy preventing proper cuff placement are excluded. Continuous and intermittent blood pressure recordings will be analyzed for agreement, timing of changes, and feasibility of finger-cuff monitoring in the outpatient surgical setting at the University of Rochester Medical Center.

Who should consider this trial

Good fit: Adults aged 18 or older with ASA physical status 2 or higher who are scheduled for elective noncardiac outpatient surgery using standard oscillometric arm cuff blood pressure monitoring and who can wear finger cuffs and give consent.

Not a fit: People who are pregnant, have an arterial pressure catheter, a large blood pressure difference between arms, Raynaud's disease, finger or hand deformities, or anatomy preventing finger cuff placement are excluded and unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, continuous finger-cuff monitoring could reveal short blood pressure swings missed by intermittent arm cuffs and help clinicians manage blood pressure more precisely during outpatient surgery.

How similar studies have performed: Similar continuous finger-cuff technologies have demonstrated reasonable agreement with invasive arterial monitoring in some clinical studies, though accuracy varies by device and patient condition.

Eligibility criteria

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)

Where this trial is running

Rochester, New York

• University of Rochester Medical Center — Rochester, New York, United States (RECRUITING)

Study contacts

• Study coordinator: Cristina Johnson

Conditions: Blood Pressure