Comparison of Non-invasive Vs. Invasive Hemodynamic Measurements

Nihon Kohden8 enrolled

Overview

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

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

Conditions

Heart Failure，Congestive

Interventions

Non-invasive central venous pressureDEVICE

Non-invasive method to measure central venous pressure indicator

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adult age over 18 years. 2. Arm circumference is 23 cm to 55 cm 3. Subject will have an existing 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

Locations (1)

El Camino Hospital

Mountain View, California, United States

Outcomes

Primary Outcomes

Non-invasive pressure indicator

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)

Time frame: 12-72 hours

Secondary Outcomes

Direction of change

Correlate the directionality of ezCVP change to invasive CVP change over time (i.e., increasing, decreasing or remaining stable).

Time frame: 12-72 hours

Correlation with invasive CVP

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

Time frame: 12-72 hours

Data from ClinicalTrials.gov

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