Accuracy of ECOM Plus Versus Pulmonary Artery Catheter

ECOM Medical

Status: Completed

Conditions: Hemodynamic Monitoring

Treatments: Device: ECOM cardiac output

Study type: Interventional

Funder types: Industry

Identifiers

NCT04858126

ECOM SP 20-007

Details and patient eligibility

About

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.

Full 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).

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

Single Group Assignment

Experimental group

Description:

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

Treatment:

Device: ECOM cardiac output