NCT01877941

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myocardial Infarction
• Myocardial Ischemia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-11-01
• Completion: 2013-12-01
• First posted: 2013-06-14
• Last updated: 2015-01-01
• Results posted: 2015-01-01

Locations

2 sites across 1 country: United States