Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2026-01-17 @ 2:29 AM
Study NCT ID:
NCT02382120
Status:
COMPLETED
Last Update Posted:
2018-08-02
First Post:
2015-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy of Non-invasive Effective Pulmonary Perfusion Measurement by CO2
Sponsor:
Hospital Privado de Comunidad de Mar del Plata
Organization:
Study Overview
Official Title:
Accuracy and Precision of Non-invasive Effective Pulmonary Perfusion Measurement Using Volumetric Capnography
Status:
COMPLETED
Status Verified Date:
2018-05
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:
Cardiac output monitoring is mandatory in most surgical and critical care patients. Many techniques to assess cardiac output are invasive and/or have many limitations, contraindications and drawbacks. The measurement of cardiac output throughout the CO2 signal is an interesting option due to the simplicity and non-invasive nature of its calculation.
The present study was designed to compare the cardiac output measurement using a capnodynamic formula versus the reference thermodilution method.
The present study was designed to compare the cardiac output measurement using a capnodynamic formula versus the reference thermodilution method.
Detailed Description:
This is a prospective and observational study designed to test the accuracy and precision of the non-invasive capnodynamic cardiac output measurement in mechanically ventilated patients. We will study 30 patients undergoing cardiovascular by pass in which an invasive trans-thoracic thermodilution method (PICCOScience) is indicated - the reference method.
A pair of thermodilutions and capnodynamic cardiac output measurement will be performed along the surgery. Analysis of precision will be done at the begining of the protocol and during stable hemodynamic conditions. Accuracy will then assessed using the Bland-Altmann plot and regression analysis.
A pair of thermodilutions and capnodynamic cardiac output measurement will be performed along the surgery. Analysis of precision will be done at the begining of the protocol and during stable hemodynamic conditions. Accuracy will then assessed using the Bland-Altmann plot and regression analysis.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: