Comparison of Non-invasive vs. Invasive Hemodynamic Measurements

Heart Failure,Congestive Clinical Trial

Official title:

Comparison Study of ezCVP and CVP

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04180202
• Other study ID #: CS-014-001
• Status: Terminated
• Start date: January 16, 2020
• Est. completion date: June 20, 2022

Study information

• Verified date: June 2022
• Source: Nihon Kohden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: June 20, 2022
• Est. primary completion date: June 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure,Congestive

Intervention

Device:
• Non-invasive central venous pressure
Non-invasive method to measure central venous pressure indicator

Locations

Country	Name	City	State
United States	El Camino Hospital	Mountain View	California

Sponsors (1)

Lead Sponsor	Collaborator
Nihon Kohden

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	12-72 hours
Secondary	Direction of change	Correlate the directionality of ezCVP change to invasive CVP change over time (i.e., increasing, decreasing or remaining stable).	12-72 hours
Secondary	Correlation with invasive CVP	Quantify the agreement between ezCVP (non-invasive) and CVP (invasive)	12-72 hours