The Continuity Study

NCT ID: NCT07216573

Last Updated: 2025-10-14

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Blood Pressure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Cohort 1 - Standard of Care

Study device data are blinded to the provider

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Edwards Lifesciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Rochester Medical Center

Rochester, New York, United States

Site Status

Countries

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United States

Central Contacts

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Cristina Johnson

Role: CONTACT

949-308-5850

Other Identifiers

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2025-06

Identifier Type: -

Identifier Source: org_study_id

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