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| Name | Class |
|---|---|
| Northern California Institute of Research and Education | OTHER |
| San Francisco Veterans Affairs Medical Center | FED |
| Drexel University | OTHER |
| Nihon Kohden |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac output monitoring | Active Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| esCCO (Estimated Continuous Cardiac Output) Monitor | 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) | During and after surgery, up to 24 hours |
| PAC (Pulmonary Artery Catheter). | 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) | During and post-surgery, up to 24 hours |
| Cardiac Output as Measured by ECOM | 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. | During and post-surgery, up to 8 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arthur Wallace, MD, PhD | San Francisco Veteran's Admnistration Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco VA Medical Center | San Francisco | California | 94121 | United States | ||
| Drexel University |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| INDUSTRY |
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| 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. |
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| 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. |
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| Philadelphia |
| Pennsylvania |
| 19102 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Continuous | Mean | Inter-Quartile Range | years |
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | esCCO (Estimated Continuous Cardiac Output) Monitor | 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) | Posted | Mean | Standard Deviation | liters/minute | During and after surgery, up to 24 hours |
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| Primary | PAC (Pulmonary Artery Catheter). | 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) | Posted | Mean | Standard Deviation | liters/minute | During and post-surgery, up to 24 hours |
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| Primary | Cardiac Output as Measured by ECOM | 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. | Supplies for the ECOM device were not available so it was not tested. | Posted | During and post-surgery, up to 8 hours |
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during surgery and during post-surgical recovery (up to 8 hours)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. No adverse events. | 0 | 39 | 0 | 39 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arthur Wallace, M.D., Ph.D. | University of California San Francisco | 415-750-2069 | 3732 | art.wallace@va.gov |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| >=65 years |
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