Clinical Evaluation of Cardiac Output Estimation Based on Pulse Wave Transit Time
- Conditions
- Myocardial InfarctionMyocardial Ischemia
- Interventions
- Device: Pulmonary Artery Catheter (PAC)Device: Endotracheal Cardiac Output Monitor (ECOM)Device: Estimated Continuous Cardiac Output (esCCO)
- Registration Number
- NCT01877941
- Lead Sponsor
- University of California, San Francisco
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
- Patients undergoing surgery where cardiac output will be measured with PAC and ECOM.
- Failure to obtain consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cardiac output monitoring Pulmonary Artery Catheter (PAC) 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). Cardiac output monitoring Endotracheal Cardiac Output Monitor (ECOM) 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). Cardiac output monitoring Estimated Continuous Cardiac Output (esCCO) 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).
- Primary Outcome Measures
Name Time Method PAC (Pulmonary Artery Catheter). 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:
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 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.
esCCO (Estimated Continuous Cardiac Output) Monitor 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:
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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
San Francisco VA Medical Center
🇺🇸San Francisco, California, United States
Drexel University
🇺🇸Philadelphia, Pennsylvania, United States