Clinical trial NCT01877941: Clinical Evaluation of Cardiac Output Estimation Based on Pulse Wave Transit Time
Official title: Clinical Evaluation of Cardiac Output Estimation Based on Pulse Wave Transit Time
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Myocardial Ischemia
Keywords: cardiac output
pulse oximetry
hemodynamics
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Northern California Institute of Research and Education
name: San Francisco Veterans Affairs Medical Center
name: Drexel University
name: Nihon Kohden
First posted: 2013-06-14
Enrollment: 39
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing surgery where cardiac output will be measured with PAC and ECOM.

Exclusion Criteria:

* Failure to obtain consent.

Primary outcomes:
measure: esCCO (Estimated Continuous Cardiac Output) Monitor
timeFrame: During and after surgery, up to 24 hours
measure: PAC (Pulmonary Artery Catheter).
timeFrame: During and post-surgery, up to 24 hours
measure: Cardiac Output as Measured by ECOM
timeFrame: During and post-surgery, up to 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center
state: California
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
Study officials:
affiliation: San Francisco Veteran's Admnistration Medical Center
name: Arthur Wallace, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: