Clinical Evaluation of Cardiac Output Estimation Based on Pulse Wave Transit Time



Status:Completed
Conditions:Angina, Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:19 - Any
Updated:2/7/2015
Start Date:December 2012
End Date:January 2015
Contact:Arthur Wallace, MD, PhD
Email:art.wallace@va.gov
Phone:(415) 750-2069

Use our guide to learn which trials are right for you!

The specific aim of this study is to assess whether a device approved by the FDA to measure
pulse oximetry can accurately estimate cardiac output.

We will compare three methods for measuring cardiac output: esCCO, PAC, and ECOM. Cardiac
output is an important physiological parameter that must be monitored closely during surgery
and during an Intensive Care Unit (ICU) stay. The use of a pulmonary artery catheter (PAC)
has been the gold standard for accurate cardiac output (CO) measurement. This method
requires a catheter to be inserted into the pulmonary artery and cardiac output is indicated
by the speed that a temperature gradient dissipates. While the use of the pulmonary artery
catheter is widespread, inserting the pulmonary artery catheter is risky, time consuming and
requires a high level of skill. For these reasons, new devices have been developed to
measure cardiac output.

A second method typically used is called ECOM (Endotracheal Cardiac Output Monitor). A
device is inserted into the patient's throat that calculates cardiac output by measuring how
electricity moves through the patient's chest.

The third method, estimated Continuous Cardiac Output (esCCO), uses sensors placed on the
patient's finger, arm and chest to calculate Pulse Wave Transit Time (PWTT); the time it
takes for the heart beat pulse to travel through the patient's body. The esCCO system is FDA
approved for safety and efficacy to measure noninvasive blood pressure and pulse oximetry.
The purpose of this study is to assess whether the PSTT calculation provides a cardiac
output measure that is comparable to the other methods.

This study is sponsored by Nihon Kohden Corporation who owns and manufactures the esCCO
system.

Inclusion Criteria:

- Patients undergoing surgery where cardiac output will be measured with PAC and ECOM.

Exclusion Criteria:

- Failure to obtain consent.
We found this trial at
2
sites
San Francisco, California 94121
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
3301 Lancaster Avenue
Philadelphia, Pennsylvania 19102
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials