Ignite Creation Date:
2024-05-06 @ 4:03 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04858126
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2021-04-21
Brief Title:
Accuracy of ECOM Plus Versus Pulmonary Artery Catheter
Sponsor:
ECOM Medical Inc
Organization:
ECOM Medical Inc
Study Overview
Official Title:
Accuracy of the ECOM Plus Hemodynamic Monitor Versus Pulmonary Artery Catheter
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None