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OpenTrials
Completed

NCT Number: NCT02382120

Accuracy of Non-invasive Effective Pulmonary Perfusion Measurement by CO2

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.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Privado de Comunidad

Mar del Plata, Buenos Aires, 7600, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Accuracy and precision of capnodynamic to measure cardiac output

    Time frame: 8 months

    Comparison between a reference method (thermodilution) with a new one (capnodynamics)

Sponsors and collaborators

Lead sponsor

Hospital Privado de Comunidad de Mar del Plata

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 6, 2015
Registry last updated
Aug 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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