Accuracy of ECOM Plus Versus Pulmonary Artery Catheter

Hemodynamic Monitoring Clinical Trial

Official title:

Accuracy of the ECOM Plus Hemodynamic Monitor Versus Pulmonary Artery Catheter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04858126
• Other study ID #: ECOM SP 20-007
• Status: Completed
• Phase: N/A
• 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
• 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-Trac® 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.

Related Conditions & MeSH terms

• Hemodynamic Monitoring

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.