Central Venous Pressure Clinical Trial
Official title:
A Prospective, Comparative Study to Evaluate the Accuracy of a Non-Invasive Central Venous Pressure Method to the Standard CVP Method
NCT number | NCT03705299 |
Other study ID # | 12-121 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 12, 2012 |
Est. completion date | April 6, 2018 |
Verified date | July 2018 |
Source | The Cooper Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a prospective, comparative, internally controlled device study that will enroll a total of 100 adult patients that require the placement of central venous catheter and CVP monitoring to assess volume status and cardiac preload.
Status | Completed |
Enrollment | 40 |
Est. completion date | April 6, 2018 |
Est. primary completion date | April 6, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients aged = 18 years - Require CVP monitoring in the supine position as part of routine care - Central venous access obtained by either internal or external jugular, or subclavian vein Exclusion Criteria: - Patients aged < 18 years - Patients who are pregnant - Patients that will be in the prone position - Central venous access obtained by the femoral vein |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
The Cooper Health System | NeuroDx Development |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessing if the NeuMeDx NICVP device is as effective as the standard invasive method at measuring CVP in patients that require central catheter placement and monitoring. | The primary objective of the study is to measure the CVP using the NeuMeDx NICVP (Non-Invasive Central Venous Pressure) device. The critical endpoint is the average of the average of three CVP, by calibrated forced transducer, and NICVP measurements in mmHg over a 10-minute period in a patient in the supine position. | 6 months |
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