Accuracy of ECOM Plus Versus Pulmonary Artery Catheter

February 16, 2024 updated by: ECOM Medical, Inc.

Accuracy of the ECOM Plus Hemodynamic Monitor Versus Pulmonary Artery Catheter

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94121
        • VA San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of ECOM Plus impedance and thermal dilution cardiac output measurements
Time Frame: 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.
6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ECOM Medical, Inc.

Investigators

  • Principal Investigator: Arthur Wallace, MD, VA San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

September 11, 2023

Study Completion (Actual)

September 11, 2023

Study Registration Dates

First Submitted

April 21, 2021

First Submitted That Met QC Criteria

April 23, 2021

First Posted (Actual)

April 26, 2021

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • ECOM SP 20-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data and information for 510(k).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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