Comparison of Non-invasive Vs. Invasive Hemodynamic Measurements

Terminated

• Conditions: Heart Failure，Congestive

• Registration Number: NCT04180202
• Lead Sponsor: Nihon Kohden

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-11-25
• Study First Submitted QC: 2019-11-25
• Study First Posted: 2019-11-27
• Study Start: 2020-01-16
• Primary Completion: 2022-06-20
• Study Completion: 2022-06-20
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-21
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Non-invasive pressure indicator	12-72 hours	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 Outcome Measures

Name	Time	Method
Direction of change	12-72 hours	Correlate the directionality of ezCVP change to invasive CVP change over time (i.e., increasing, decreasing or remaining stable).
Correlation with invasive CVP	12-72 hours	Quantify the agreement between ezCVP (non-invasive) and CVP (invasive)

Trial Locations

Locations (1)

El Camino Hospital; 🇺🇸 Mountain View, California, United States