Comparison of Non-invasive Vs. Invasive Hemodynamic Measurements

NCT04180202 | Terminated FDA Device

• 1 other identifier: CS-014-001
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure，Congestive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Direction of change

  12-72 hours

• Correlation with invasive CVP

  12-72 hours

Interventions

Non-invasive central venous pressure DEVICE

Non-invasive method to measure central venous pressure indicator

Also known as: ezCVP, CVPni

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the El Camino Hospital ICU with central venous catheter.

You may qualify if:

• Adult age over 18 years.
• Arm circumference is 23 cm to 55 cm
• Subject will have an existing central venous catheter during their ICU stay
• 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
• Subject or LAR is willing and able to comply with protocol procedures

You may not qualify if:

• Finger and/or 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 deep venous thrombosis currently being treated
• Severe skin disease involving the upper arm(s)
• Study investigator may exclude patients based on clinical judgement

Sponsors & Collaborators

• Nihon Kohden: lead

Study Sites (1)

El Camino Hospital

Mountain View, California, 94040, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Zachary Edmonds, MD

  Palo Alto Foundation Medical Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: November 27, 2019
• Study Start: January 16, 2020
• Primary Completion: June 20, 2022
• Study Completion: June 20, 2022
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)