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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04858126
Other study ID # ECOM SP 20-007
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2021
Est. completion date September 11, 2023

Study information

Verified date January 2023
Source ECOM Medical, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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-TracĀ® System (Edwards LifeSciences).


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date September 11, 2023
Est. primary completion date September 11, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
ECOM cardiac output
Measure cardiac output during perioperative period and compare to pulmonary artery catheter thermal dilution cardiac output measurement.

Locations

Country Name City State
United States VA San Francisco San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
ECOM Medical, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Wallace AW, Salahieh A, Lawrence A, Spector K, Owens C, Alonso D. Endotracheal cardiac output monitor. Anesthesiology. 2000 Jan;92(1):178-89. doi: 10.1097/00000542-200001000-00030. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
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