Clinical Evaluation of Cardiac Output Estimation Based on Pulse Wave Transit Time (esCCO)
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Clinical Evaluation of Cardiac Output Estimation Based on Pulse Wave Transit Time|
- 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).
- 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)
|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)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01877941
|Contact: Arthur Wallace, MD, PhD||(415) firstname.lastname@example.org|
|Contact: Steven Takemoto, PhD||(415) 221-4810 ext email@example.com|
|United States, California|
|San Francisco VA Medical Center||Recruiting|
|San Francisco, California, United States, 94121|
|Contact: Art Wallace, MD, PhD 415-750-2069 firstname.lastname@example.org;|
|Principal Investigator: Art Wallace, MD, PhD|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19102|
|Contact: Ashish Sinha, MD, PhD|
|Principal Investigator: Ashish Sinha, MD, PhD|
|Principal Investigator:||Arthur Wallace, MD, PhD||San Francisco Veteran's Admnistration Medical Center|