Comparison of Noninvasive vs. Invasive Hemodynamic Measurements

February 10, 2026 updated by: Nihon Kohden

Comparison Study of ezCVP and CVP

Comparison of a non-invasive method of measuring central venous pressure to the conventional modality of invasive central venous pressure.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The conventional method used to measure central venous pressure has limitations since it is an invasive procedure that requires a central venous catheter. To overcome this challenge, a new technology to assess CVP non-invasively using an oscillometric method is being developed. It is called enclosed zone central venous pressure (ezCVP). A comparison study of ezCVP and CVP is needed to determine accuracy and reproducibility.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

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

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University Hospital

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

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to the Stanford University Hospital ICU with central venous catheter.

Description

Inclusion Criteria:

  1. Adult age over 18 years.
  2. Arm circumference is 18 cm to 55 cm
  3. Subject will have an existing indwelling central venous catheter during their ICU stay
  4. Subject or legally authorized representative (LAR) is able to understand the risks and potential benefits of participating in the study and is willing to provide written informed consent
  5. Subject or LAR is willing and able to comply with protocol procedures

Exclusion Criteria:

  1. Finger and/or upper arm anatomical anomaly or disease that may interfere with attaching a pulse oximeter sensor and/or blood pressure cuff.
  2. Pregnant (self-reported)
  3. Upper extremity deep venous thrombosis currently being treated
  4. Severe skin disease involving the upper arm(s)
  5. Study investigator may exclude patients based on clinical judgement

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-invasive pressure indicator
Time Frame: 1-7 days
Evaluate sensitivity and specificity of ezCVP indication based on the case where CVP is in a 'low range' (0 < CVP < 10 mmHg) or 'high range' (>= 10 mmHg)
1-7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Direction of change
Time Frame: 1-7 days
Correlate the directionality of ezCVP change to invasive CVP change over time (i.e., increasing, decreasing or remaining stable).
1-7 days
Correlation with invasive CVP
Time Frame: 1-7 days
Quantify the agreement between ezCVP (non-invasive) and CVP (invasive)
1-7 days

Collaborators and Investigators

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

Sponsor

Nihon Kohden

Investigators

  • Principal Investigator: Masataka Kawana, MD, Stanford University

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 (Actual)

October 21, 2024

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

March 30, 2027

Study Registration Dates

First Submitted

November 12, 2024

First Submitted That Met QC Criteria

November 12, 2024

First Posted (Actual)

November 14, 2024

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 74Ag- 00009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual participant data will be shared. Aggregate results will be published by the investigators in academic journals.

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.

Clinical Trials on Heart Failure, Congestive

Clinical Trials on Non-invasive central venous pressure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe