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NCT Number: NCT06689215

Comparison of Noninvasive vs. Invasive Hemodynamic Measurements

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Heart Failure, Congestive Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University Hospital

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult age over 18 years.
  • Arm circumference is 18 cm to 55 cm
  • Subject will have an existing indwelling central venous catheter during their ICU stay
  • 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
  • Subject or LAR is willing and able to comply with protocol procedures

Exclusion criteria

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

Treatment and study plan

Non-invasive central venous pressure

Device

Non-invasive method to measure central venous pressure indicator

Other names: ezCVP, CVPni

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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).

  2. Correlation with invasive CVP

    Time frame: 1-7 days

    Quantify the agreement between ezCVP (non-invasive) and CVP (invasive)

Sponsors and collaborators

Lead sponsor

Nihon Kohden

Industry

Registry information

Official study title

Comparison Study of ezCVP and CVP

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Nov 14, 2024
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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