Accuracy of ECOM Plus Versus Pulmonary Artery Catheter

Study Overview
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Brief Summary
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This Study will compare the accuracy of the ECOM Plus Endotracheal Cardiac Output Monitor (ECOM) without the use of the arterial pressure waveform from the arterial line to 1) the current clinical standard of cardiac output measured by intermittent room temperature bolus thermodilution using a PAC, 2) the current ECOM System with the use of the arterial blood pressure waveform from a radial arterial line and 3) the Flo-Trac® System.

Detailed Description
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This Study will compare the accuracy of the ECOM Plus Endotracheal Cardiac Output Monitor (ECOM) without the use of the arterial pressure waveform from the arterial line to 1) the current clinical standard of cardiac output measured by intermittent room temperature bolus thermodilution using a PAC, 2) the current ECOM System with the use of the arterial blood pressure waveform from a radial arterial line and 3) the Flo-Trac® System (Edwards LifeSciences).

Official Title
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Accuracy of the ECOM Plus Hemodynamic Monitor Versus Pulmonary Artery Catheter

Conditions
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Hemodynamic Monitoring

Intervention / Treatment
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* Device: ECOM cardiac output


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients able to give informed consent. Patients undergoing surgery that would routinely require use of an endotracheal, pulmonary artery catheter and arterial catheter. Exclusion Criteria: Patients who do not speak English. Patients not competent to give informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Group Assignment<br>ECOM endotracheal cardiac output monitor in patients undergoing cardiac and liver surgery. | Device: ECOM cardiac output<br>* Measure cardiac output during perioperative period and compare to pulmonary artery catheter thermal dilution cardiac output measurement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of ECOM Plus impedance and thermal dilution cardiac output measurements | Correlation via linear regression between thermal dilution and ECOM Plus included as an R to coefficient. Cardiac output measured by thermal dilution and impedance cardiography. Management of the patients using standard thermal dilution derived CO measurement only. The ECOM Plus measurement output are for research purposes only and not to be used in the management of the patient. ECOM Plus impedance cardiography measured in the ICU when routine thermal dilution CO measurements are made. Continued impedance measurements until tracheal extubation. | 6 months. |