The Continuity Study

Part of paid clinical trials in Rochester, New York.

Sponsor
Edwards Lifesciences
Study ID
NCT07216573
Status
Recruiting
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Conditions

  • Blood Pressure

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
May 7, 2026
Status verified
Jun 2026
Primary completion
Jan 31, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
188 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Experimental: Cohort 1 - Standard of Care
    Study device data are blinded to the provider
  • Experimental: Cohort 2 - Standard of Care with cNIBP Monitoring
    Study device continuous non-invasive blood pressure data are unblinded to the provider

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Rochester Medical CenterRochesterNew York14620-

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By research site
University of Rochester Medical Center· Rochester, NY

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