Accuracy of ECOM Plus Versus Pulmonary Artery Catheter

NCT04858126 | Completed FDA Device

• 1 other identifier: ECOM SP 20-007
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodynamic Monitoring

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Single Group Assignment

EXPERIMENTAL

ECOM endotracheal cardiac output monitor in patients undergoing cardiac and liver surgery.

Device: ECOM cardiac output

Interventions

ECOM cardiac output DEVICE

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

Single Group Assignment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients able to give informed consent.
• Patients undergoing surgery that would routinely require use of an endotracheal, pulmonary artery catheter and arterial catheter.

You may not qualify if:

• Patients who do not speak English.
• Patients not competent to give informed consent.

Sponsors & Collaborators

• ECOM Medical, Inc.: lead

Study Sites (1)

VA San Francisco

San Francisco, California, 94121, United States

Location

Related 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.

  PMID: 10638915 BACKGROUND

Study Officials

• Arthur Wallace, MD

  VA San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 26, 2021
• Study Start: January 1, 2021
• Primary Completion: September 11, 2023
• Study Completion: September 11, 2023
• Last Updated: February 20, 2024

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)