Study for the Evaluation of a Non-invasive Hemodynamic Measurement in Heart Failure Patients

Part of paid clinical trials in Palo Alto, California.

Sponsor
Nihon Kohden
Study ID
NCT05441696
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

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

Interventions

  • ezCVP measurement — DEVICE
    * Measuring device: non-FDA-cleared patient monitor (740E, Zoe Medical, MA, US), which has software to measure ezCVP. * Sensor: an FDA-cleared pulse oximeter sensor for adults (K012891: DS-100A, Nellcor, CA, US). * Cuff: an FDA-cleared NIBP cuff for adults (K080342: YP-713T, YP-714T or TP-715T, Nihon Kohden Corporation, Tokyo, Japan).

Study Details

Track changes in non-invasive central venous pressure across hospital stay and relationship with readmission

Key Dates

Start date
Jun 1, 2022
Status verified
Mar 2024
Primary completion
Sep 30, 2025
Completion
Sep 29, 2026

Study Design

Enrollment
65 participants (estimated)

Arms

  • Arm: Adult CHF subjects with initial high CVP
    Adult subjects with congestive heart failure diagnosis who have an indicated high non-invasive estimated central venous pressure on first measurement after clinical unit admission.
  • Arm: Adult CHF subjects with initial low CVP
    Adult subjects with congestive heart failure diagnosis who have an indicated low non-invasive estimated central venous pressure on first measurement after clinical unit admission.

Primary Outcome Measure

Evaluate the difference between non-invasive CVP measurement at admission and at discharge [ Time Frame: 7 days ]

Locations (2)

FacilityCityStateZIPSite coordinators
Veterans Affairs HospitalPalo AltoCalifornia94304-
Stanford Medical CenterStanfordCalifornia94305-

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