NCT04858126

Accuracy of ECOM Plus Versus Pulmonary Artery Catheter

Accuracy of the ECOM Plus Hemodynamic Monitor Versus Pulmonary Artery Catheter

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: ECOM Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Hemodynamic Monitoring

Interventions

Type	Name	Description
DEVICE	ECOM cardiac output	Measure cardiac output during perioperative period and compare to pulmonary artery catheter thermal dilution cardiac output measurement.

Timeline

• Start date: 2021-01-01
• Primary completion: 2023-09-11
• Completion: 2023-09-11
• First posted: 2021-04-26
• Last updated: 2024-02-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study