Comparison of Noninvasive Vs. Invasive Hemodynamic Measurements

Nihon Kohden

Status: Invitation-only

Conditions: Heart Failure, Congestive

Treatments: Device: Non-invasive central venous pressure

Study type: Observational

Funder types: Industry

Identifiers

NCT06689215

74Ag- 00009

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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