Accuracy of Non-invasive Effective Pulmonary Perfusion Measurement by CO2

NCT ID: NCT02382120

Last Updated: 2018-08-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-02
• Study Completion Date: 2018-07-21

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.

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.

Conditions

Cardiovascular Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients undergoing cardiovascular surgery

Patients ASA 3-4 undergoing cardiac surgery.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Privado de Comunidad de Mar del Plata

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerardo Tusman, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Privado de Comunidad de Mar del Plata

Locations

Hospital Privado de Comunidad

Mar del Plata, Buenos Aires, Argentina

Countries

Argentina

References

Capek JM, Roy RJ. Noninvasive measurement of cardiac output using partial CO2 rebreathing. IEEE Trans Biomed Eng. 1988 Sep;35(9):653-61. doi: 10.1109/10.7266. No abstract available.

Reference Type: BACKGROUND

PMID: 3139547 (View on PubMed)

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. doi: 10.1097/00000542-200607000-00015.

Reference Type: RESULT

PMID: 16809997 (View on PubMed)

Other Identifiers

23022015

Identifier Type: -

Identifier Source: org_study_id