Hemodynamic Monitoring
Conditions
Brief summary
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
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).
Interventions
DEVICEECOM cardiac output
Measure cardiac output during perioperative period and compare to pulmonary artery catheter thermal dilution cardiac output measurement.
Sponsors
ECOM Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of ECOM Plus impedance and thermal dilution cardiac output measurements | 6 months. | 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. |
Countries
United States
Outcome results
None listed