Heart Failure, Congestive
Conditions
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.
Interventions
Non-invasive method to measure central venous pressure indicator
Sponsors
Nihon Kohden
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non-invasive pressure indicator | 1-7 days | 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
| Measure | Time frame | Description |
|---|---|---|
| Direction of change | 1-7 days | Correlate the directionality of ezCVP change to invasive CVP change over time (i.e., increasing, decreasing or remaining stable). |
| Correlation with invasive CVP | 1-7 days | Quantify the agreement between ezCVP (non-invasive) and CVP (invasive) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMasataka Kawana, MD
Stanford University
Outcome results
None listed