Accuracy of ECOM Plus Versus Pulmonary Artery Catheter

NCT ID: NCT04858126

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-09-11

Brief Summary

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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

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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

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Hemodynamic Monitoring

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Single Group Assignment

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

Group Type EXPERIMENTAL

ECOM cardiac output

Intervention Type DEVICE

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

Interventions

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ECOM cardiac output

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ECOM Medical, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arthur Wallace, MD

Role: PRINCIPAL_INVESTIGATOR

VA San Francisco

Locations

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VA San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 10638915 (View on PubMed)

Other Identifiers

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ECOM SP 20-007

Identifier Type: -

Identifier Source: org_study_id

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