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

This study has been completed.
Sponsor:
Collaborators:
Northern California Institute of Research and Education
San Francisco Veterans Administration Medical Center
Drexel University
Nihon Kohden
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01877941
First received: December 5, 2012
Last updated: December 30, 2014
Last verified: December 2014
  Purpose

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.


Condition Intervention
Myocardial Infarction
Myocardial Ischemia
Device: Pulmonary Artery Catheter (PAC)
Device: Endotracheal Cardiac Output Monitor (ECOM)
Device: Estimated Continuous Cardiac Output (esCCO)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of Cardiac Output Estimation Based on Pulse Wave Transit Time

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • esCCO (Estimated Continuous Cardiac Output) Monitor [ Time Frame: During and after surgery, up to 24 hours ] [ Designated as safety issue: No ]

    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:

    1. 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)


  • PAC (Pulmonary Artery Catheter). [ Time Frame: During and post-surgery, up to 24 hours ] [ Designated as safety issue: No ]

    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:

    1. 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)


  • Cardiac Output as Measured by ECOM [ Time Frame: During and post-surgery, up to 8 hours ] [ Designated as safety issue: No ]
    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.


Enrollment: 39
Study Start Date: December 2012
Study Completion Date: December 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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).
Device: 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.
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.
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.

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Failure to obtain consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01877941

Locations
United States, California
San Francisco VA Medical Center
San Francisco, California, United States, 94121
United States, Pennsylvania
Drexel University
Philadelphia, Pennsylvania, United States, 19102
Sponsors and Collaborators
University of California, San Francisco
Northern California Institute of Research and Education
San Francisco Veterans Administration Medical Center
Drexel University
Nihon Kohden
Investigators
Principal Investigator: Arthur Wallace, MD, PhD San Francisco Veteran's Admnistration Medical Center
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01877941     History of Changes
Other Study ID Numbers: UCSF 12-10139
Study First Received: December 5, 2012
Results First Received: October 16, 2014
Last Updated: December 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
cardiac output
pulse oximetry
hemodynamics

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Infarction
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 29, 2015