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

NCT ID: NCT01877941

Last Updated: 2015-01-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2013-12-31

Brief Summary

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.

Detailed 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.

Conditions

Myocardial Infarction; Myocardial Ischemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Cardiac output monitoring

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).

Group Type: ACTIVE_COMPARATOR

Pulmonary Artery Catheter (PAC)

Intervention Type: DEVICE

A catheter is inserted into the pulmonary artery, through the internal jugular vein; cardiac output is indicated by the speed that a temperature gradient dissipates.

Endotracheal Cardiac Output Monitor (ECOM)

Intervention Type: DEVICE

An FDA-approved medical device is inserted into the patient's throat; cardiac output is calculated by measuring how electricity moves through the chest.

Estimated Continuous Cardiac Output (esCCO)

Intervention Type: DEVICE

Sensors are placed on the arm, finger and leg to calculate Pulse Wave Transit Time (PWTT); the time it takes for the pulse of the heartbeat to travel through the body.

Interventions

Pulmonary Artery Catheter (PAC)

A catheter is inserted into the pulmonary artery, through the internal jugular vein; cardiac output is indicated by the speed that a temperature gradient dissipates.

Intervention Type: DEVICE

Endotracheal Cardiac Output Monitor (ECOM)

An FDA-approved medical device is inserted into the patient's throat; cardiac output is calculated by measuring how electricity moves through the chest.

Intervention Type: DEVICE

Estimated Continuous Cardiac Output (esCCO)

Sensors are placed on the arm, finger and leg to calculate Pulse Wave Transit Time (PWTT); the time it takes for the pulse of the heartbeat to travel through the body.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Failure to obtain consent.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northern California Institute of Research and Education

OTHER

Sponsor Role: collaborator

San Francisco Veterans Affairs Medical Center

FED

Sponsor Role: collaborator

Drexel University

OTHER

Sponsor Role: collaborator

Nihon Kohden

INDUSTRY

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arthur Wallace, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

San Francisco Veteran's Admnistration Medical Center

Locations

San Francisco VA Medical Center

San Francisco, California, United States

Drexel University

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

UCSF 12-10139

Identifier Type: -

Identifier Source: org_study_id