The Continuity Study

Edwards Lifesciences

Status: Not yet enrolling

Conditions: Blood Pressure

Treatments: Device: HemoSphere Vita Monitor, VitaWave or VitaWave Plus Finger Cuff Adult, ForeSight Large Sensors

Study type: Interventional

Funder types: Industry

Identifiers

NCT07216573

2025-06

Details and patient eligibility

About

A before & after interventional cohort study comparing intermittent blood pressure measurement using the oscillometric arm cuff to continuous noninvasive blood pressure measurement using the VitaWave finger cuffs in subjects undergoing elective surgery in an outpatient setting.

Enrollment: 188 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed informed consent
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

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)

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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188 participants in 2 patient groups

Cohort 1 - Standard of Care

Experimental group

Description:

Study device data are blinded to the provider

Treatment:

Device: HemoSphere Vita Monitor, VitaWave or VitaWave Plus Finger Cuff Adult, ForeSight Large Sensors

Cohort 2 - Standard of Care with cNIBP Monitoring

Experimental group

Description:

Study device continuous non-invasive blood pressure data are unblinded to the provider

Treatment:

Device: HemoSphere Vita Monitor, VitaWave or VitaWave Plus Finger Cuff Adult, ForeSight Large Sensors