The Continuity Study

April 18, 2026 updated by: Edwards Lifesciences

Continuous Blood Pressure Monitoring During Outpatient Surgery

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

188

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14620
        • Recruiting
        • University of Rochester Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1 - Standard of Care
Study device data are blinded to the provider
Device: HemoSphere Vita Monitor with VitaWave or VitaWave Plus Finger Cuff Adult, and ForeSight Large Sensors
Devices are applied for monitoring throughout the duration of the procedure
Experimental: Cohort 2 - Standard of Care with cNIBP Monitoring
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
Devices are applied for monitoring throughout the duration of the procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: Through Study Completion, approximately 12 months
Through Study Completion, approximately 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edwards Lifesciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

September 19, 2025

First Submitted That Met QC Criteria

October 9, 2025

First Posted (Actual)

October 14, 2025

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 18, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 2025-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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