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Completed

NCT Number: NCT01877941

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

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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Francisco VA Medical Center, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Failure to obtain consent.

Treatment and study plan

Pulmonary Artery Catheter (PAC)

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)

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)

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.

Primary outcomes

  1. esCCO (Estimated Continuous Cardiac Output) Monitor

    Time frame: During and after surgery, up to 24 hours

    6 Measurements of cardiac output derived from pulse oximeter measurements using the esCCO system were taken at each time point. The measurements deemed valid under the criteria in the protocol were averaged to represent the reference value at that point. The mean and standard deviation reported consist of the reference values from all time points measured.

    Data for this test were taken at the following timepoints:

    • Start of Sterenotomy; 2. Before Bypass; 3. 30 Min after bypass; 4. Closure; 5. ICU arrival; 6. 6 hours in ICU; 7. 12 Hours in ICU; 8. 18 Hours in ICU (if PAC still in); 9. 24 Hours in ICU (If PAC still in)

  2. PAC (Pulmonary Artery Catheter).

    Time frame: During and post-surgery, up to 24 hours

    Measurements of cardiac output derived from a PAC (pulmonary artery catheter) using the standard thermodilution technique. At each time point, at least 6 measurements were taken. If, in the opinion of the clinician taking the readings, some of these were in error, more readings were taken to ensure accuracy. In no case were more than 18 readings taken. The points deemed valid by the clinician were averaged to obtain the reference value for that time point. The mean and standard deviation reported consisted of the reference values from all time points measured.

    Data for this test were taken at the following timepoints:

    • Start of Sterenotomy; 2. Before Bypass; 3. 30 Min after bypass; 4. Closure; 5. ICU arrival; 6. 6 hours in ICU; 7. 12 Hours in ICU; 8. 18 Hours in ICU (if PAC still in); 9. 24 Hours in ICU (If PAC still in)

  3. Cardiac Output as Measured by ECOM

    Time frame: During and post-surgery, up to 8 hours

    Measurements of cardiac output derived from the 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Drexel University
  • Nihon Kohden
  • Northern California Institute of Research and Education
  • San Francisco Veterans Affairs Medical Center

Registry information

Acronym: esCCO

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 14, 2013
Registry last updated
Jan 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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