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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of California, San Francisco
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: June 11, 2013
Last verified: June 2013
  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
Myocardial Infarction
Myocardial Ischemia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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: estimated up to 8 hours ] [ Designated as safety issue: No ]
    Measurements of cardiac output derived from pulse oximeter measurements using the esCCO system

  • PAC (pulmonary artery catheter). [ Time Frame: up to 8 hours ] [ Designated as safety issue: No ]
    Measurements of cardiac output derived from a PAC (pulmonary artery catheter).


Secondary Outcome Measures:
  • endotracheal tube (ECOM or Endotracheal Cardiac Output Monitor) [ Time Frame: up to 7 days post surgery ] [ Designated as safety issue: No ]
    compare measurements of cardiac output derived from electrical measurements from electrodes on an endotracheal tube (ECOM or Endotracheal Cardiac Output Monitor) to those made from a PAC (pulmonary artery thermodilution catheter)

  • PAC (pulmonary artery thermodilution catheter) [ Time Frame: up to 7 days post surgery ] [ Designated as safety issue: No ]
    compare measurements of cardiac output derived from electrical measurements from electrodes on an endotracheal tube (ECOM or Endotracheal Cardiac Output Monitor) to those made from a PAC (pulmonary artery thermodilution catheter)


Estimated Enrollment: 100
Study Start Date: December 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cardiac output monitoring
Patients undergoing surgery who will have their cardiac output monitored during surgery and during post-surgical recovery. For instance, patients with ischemic heart disease undergoing cardiac bypass graft or percutaneous coronary intervention.

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
Sampling Method:   Non-Probability Sample
Study Population

Approximately 100 patients preparing to undergo a surgical procedure where cardiac monitoring will be performed.

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

Contacts
Contact: Arthur Wallace, MD, PhD (415) 750-2069 art.wallace@va.gov
Contact: Steven Takemoto, PhD (415) 221-4810 ext 3116 steven.takemoto@va.gov

Locations
United States, California
San Francisco VA Medical Center Recruiting
San Francisco, California, United States, 94121
Contact: Art Wallace, MD, PhD    415-750-2069    art.wallace@va.gov;   
Principal Investigator: Art Wallace, MD, PhD         
United States, Pennsylvania
Drexel University Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Ashish Sinha, MD, PhD         
Principal Investigator: Ashish Sinha, MD, PhD         
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
Last Updated: June 11, 2013
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
Heart Diseases
Coronary Disease
Infarction
Myocardial Infarction
Myocardial Ischemia
Ischemia
Pathologic Processes
Necrosis
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on September 18, 2014