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

Launched by NIHON KOHDEN · Jun 28, 2022

Keywords

ClinConnect Summary

Determining the degree of congestion is important in deciding appropriate timing for discharging hospitalized heart failure patients. Central venous pressure (CVP) reflects the returning blood volume to the heart and can guide therapy to relieve congestion. However, the conventional method used to measure CVP has notable limitations as it is an invasive procedure that requires placement of a central venous catheter.

Traditional, non-invasive methods of estimating CVP, such as physical examination and echocardiogram, are less accurate and more resource intensive. To overcome this challenge,...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Arm circumference of 23 cm to 55 cm
• • Subject admitted to the hospital with acute exacerbation of heart failure, with either reduced or preserved ejection fraction
• • Subject is at risk for readmission (NYHA Functional Classification 2-3)
• • Subject is able to understand the risks and potential benefits of participating in the study and is willing to provide written, informed consent
• • ezCVP indicator is high (CVPNI is over 9 mmHg) at admission
• • Subject is willing and able to comply with protocol procedures
• • Subject tested negative for COVID test after admission to the hospital
• Exclusion Criteria:
• • Finger and 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 DVT (currently being treated)
• • Severe skin disease involving the upper arm(s)
• • Study investigator may exclude patients based on clinical judgement