Accuracy of Non-invasive Effective Pulmonary Perfusion Measurement by CO2

Cardiovascular Disease Clinical Trial

Official title:

Accuracy and Precision of Non-invasive Effective Pulmonary Perfusion Measurement Using Volumetric Capnography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02382120
• Other study ID #: 23022015
• Status: Completed
• Start date: March 2, 2015
• Est. completion date: July 21, 2018

Study information

• Verified date: May 2018
• Source: Hospital Privado de Comunidad de Mar del Plata
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 21, 2018
• Est. primary completion date: April 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• Written informed consent

• Programmed cardiac surgeries

• Surgeries with cardiopulmonary bypass

Exclusion Criteria:

• Emergency surgeries.

• Acute pulmonary diseases

• Contraindication of femoral catheters.

• Need of counter-pulsation baloon

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Locations

Country	Name	City	State
Argentina	Hospital Privado de Comunidad	Mar del Plata	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Privado de Comunidad de Mar del Plata

Country where clinical trial is conducted

Argentina, 

References & Publications (2)

Capek JM, Roy RJ. Noninvasive measurement of cardiac output using partial CO2 rebreathing. IEEE Trans Biomed Eng. 1988 Sep;35(9):653-61. — View Citation

Peyton PJ, Venkatesan Y, Hood SG, Junor P, May C. Noninvasive, automated and continuous cardiac output monitoring by pulmonary capnodynamics: breath-by-breath comparison with ultrasonic flow probe. Anesthesiology. 2006 Jul;105(1):72-80. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy and precision of capnodynamic to measure cardiac output	Comparison between a reference method (thermodilution) with a new one (capnodynamics)	8 months