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

University of California San Francisco (UCSF)

Status: Completed

Conditions: Myocardial Ischemia; Myocardial Infarction

Treatments: Device: Endotracheal Cardiac Output Monitor (ECOM); Device: Pulmonary Artery Catheter (PAC); Device: Estimated Continuous Cardiac Output (esCCO)

Study type: Interventional

Funder types: Other; Industry; Other U.S. Federal agency

Identifiers

NCT01877941

UCSF 12-10139

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 39 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Failure to obtain consent.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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39 participants in 1 patient group

Cardiac output monitoring

Active Comparator group

Description:

Patients undergoing surgery who will have their cardiac output monitored by pulmonary artery catheter (PAC) and endotracheal cardiac output monitoring (ECOM) during surgery and during post-surgical recovery, will also have sensors placed on the arm, finger and leg to calculate pulse wave transit time (PWTT) using the estimated Continuous Cardiac Output system (ecCCO).

Treatment:

Device: Estimated Continuous Cardiac Output (esCCO)

Device: Endotracheal Cardiac Output Monitor (ECOM)

Device: Pulmonary Artery Catheter (PAC)