Accuracy of ECOM Plus Versus Pulmonary Artery Catheter

Not Applicable

Completed

• Conditions: Hemodynamic Monitoring
• Interventions: Device: ECOM cardiac output

• Registration Number: NCT04858126
• Lead Sponsor: ECOM Medical, Inc.

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).

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-04-21
• Study First Submitted QC: 2021-04-23
• Study First Posted: 2021-04-26
• Status Verified: 2023-01
• Primary Completion: 2023-09-11
• Study Completion: 2023-09-11
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Group Assignment	ECOM cardiac output	ECOM endotracheal cardiac output monitor in patients undergoing cardiac and liver surgery.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

VA San Francisco; 🇺🇸 San Francisco, California, United States