The Continuity Study

NCT07216573 | Recruiting FDA Device

• 1 other identifier: 2025-06
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Cohort 1 - Standard of Care

EXPERIMENTAL

Study device data are blinded to the provider

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

Cohort 2 - Standard of Care with cNIBP Monitoring

EXPERIMENTAL

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

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

Interventions

HemoSphere Vita Monitor with VitaWave or VitaWave Plus Finger Cuff Adult, and ForeSight Large Sensors DEVICE

Devices are applied for monitoring throughout the duration of the procedure

Cohort 1 - Standard of Care; Cohort 2 - Standard of Care with cNIBP Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Age ≥ 18 years
• American Society of Anesthesiologists (ASA) Physical Status ≥ 2
• Scheduled for elective noncardiac surgery with intermittent arterial blood pressure monitoring using oscillometric arm cuff

You may not qualify if:

• Patient who is known to be pregnant
• Patient with existing or planned arterial pressure catheter
• Patient in whom systolic arterial pressure differs by more than 20 mmHg between the right and left arms
• Inability to place oscillometric cuff on the subject's upper extremity
• 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
• Finger or hand deformity that prevents proper placement of finger cuff by visual inspection
• Inability to place finger cuffs due to subject anatomy, condition, or obstructive paraphernalia (such as false nails)

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14620, United States

RECRUITING

Central Study Contacts

Cristina Johnson

CONTACT

949-308-5850; APMContinuity.Study@bd.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: October 14, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)