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NCT Number: NCT03970980

FIO2 Influences Accuracy of Fick-based Cardiac Output

Cardiac output (CO) monitoring is often required for clinical evaluation and management in critically ill patients and during anesthesia. There are many methods to measure CO. Fick-based CO estimation (Fick-CO) is one of the most commonly used methods, while thermodilution (TD-CO) is viewed as golden standard. But Fick-CO is still widely used, especially in catheterization laboratories and pediatric cardiologic department, whose patients often with congenital heart disease. Multiple studies from the 1960s find a strong correlation between TD-CO and Fick-CO. However, more recent studies reject the conclusion. Since Fick-CO is the ratio of oxygen consumption (V'O2) to the arteriovenous difference in oxygen content, many parameters are included in the Fick equation, such as V'O2, hemoglobin (Hb), arterial oxygen saturation (SaO2), mixed venous oxygen saturation (SvO2), partial pressure of arterial oxygen (PaO2), and mixed venous oxygen tension (PvO2). Any changes of each parameter may influence the accuracy of Fick-CO calculation. This may be the reason why it remains controversial whether Fick-CO and TD-CO are interchangeable or not. Although there are lots of studies comparing Fick-CO and TD-CO, discussing the impact of V'O2 on Fick-CO, how the other parameters influence the final CO estimation are rarely focused. Therefore, the purpose of this study was to assess the influence of FIO2 on PaO2, SvO2, PvO2, and the accuracy of Fick-CO in cardiac surgery patients.

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Key information

Conditions

Cardiac Output

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Patients who are aged ≥20 years, are undergoing planned elective cardiac surgery, and provided signed informed consent are included in the present study. Any patients with cardiac arrhythmia or an intra-cardiac shunt are excluded.

The patients are randomly assigned to 2 groups: FIO2 <70% or FIO2 >90%. And during the surgery, the oximeter values are kept ≥98%. Intra-operatively, FIO2, PaO2, SvO2, PvO2, Hb, and TD-CO are recorded.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • undergoing planned elective cardiac surgery
  • agree to sign informed consent

Exclusion criteria

  • cardiac arrhythmia
  • intra-cardiac shunt

Treatment and study plan

fraction of inspired oxygen (FIO2)

Other

Different group receives different (70% vs. 90%) fraction of inspired oxygen (FIO2) during the surgery.

Primary outcomes

  1. The Hemoglobin Values in Different FIO2 Groups during Cardiac Surgeries

    Time frame: 5 minutes before surgical incision

    The patients were divided into two FIO2 groups (FIO2 >90% or <70%) during the surgery. We will collect hemoglobin data in each patient.

  2. The Hemoglobin Values in Different FIO2 Groups during Cardiac Surgeries

    Time frame: 5 minutes after finishing protamine infusion

    The patients were divided into two FIO2 groups (FIO2 >90% or <70%) during the surgery. We will collect hemoglobin data in each patient.

  3. The Oxygen Consumption in Different FIO2 Groups during Cardiac Surgeries

    Time frame: 5 minutes before surgical incision

    The patients were divided into two FIO2 groups (FIO2 >90% or <70%) during the surgery. We will calculate oxygen consumption in each patient.

  4. The Oxygen Consumption in Different FIO2 Groups during Cardiac Surgeries

    Time frame: 5 minutes after finishing protamine infusion

    The patients were divided into two FIO2 groups (FIO2 >90% or <70%) during the surgery. We will calculate oxygen consumption in each patient.

  5. The SaO2 in Different FIO2 Groups during Cardiac Surgeries

    Time frame: 5 minutes before surgical incision

    The patients were divided into two FIO2 groups (FIO2 >90% or <70%) during the surgery. We will record SaO2 data in each patient.

  6. The SaO2 in Different FIO2 Groups during Cardiac Surgeries

    Time frame: 5 minutes after finishing protamine infusion

    The patients were divided into two FIO2 groups (FIO2 >90% or <70%) during the surgery. We will record SaO2 data in each patient.

  7. The SvO2 in Different FIO2 Groups during Cardiac Surgeries

    Time frame: 5 minutes before surgical incision

    The patients were divided into two FIO2 groups (FIO2 >90% or <70%) during the surgery. We will record SvO2 data in each patient.

  8. The SvO2 in Different FIO2 Groups during Cardiac Surgeries

    Time frame: 5 minutes after finishing protamine infusion

    The patients were divided into two FIO2 groups (FIO2 >90% or <70%) during the surgery. We will record SvO2 data in each patient.

  9. The PaO2 in Different FIO2 Groups during Cardiac Surgeries

    Time frame: 5 minutes before surgical incision

    The patients were divided into two FIO2 groups (FIO2 >90% or <70%) during the surgery. We will record PaO2 data in each patient.

  10. The PaO2 in Different FIO2 Groups during Cardiac Surgeries

    Time frame: 5 minutes after finishing protamine infusion

    The patients were divided into two FIO2 groups (FIO2 >90% or <70%) during the surgery. We will record PaO2 data in each patient.

  11. The PvO2 in Different FIO2 Groups during Cardiac Surgeries

    Time frame: 5 minutes before surgical incision

    The patients were divided into two FIO2 groups (FIO2 >90% or <70%) during the surgery. We will record PvO2 data in each patient.

  12. The PvO2 in Different FIO2 Groups during Cardiac Surgeries

    Time frame: 5 minutes after finishing protamine infusion

    The patients were divided into two FIO2 groups (FIO2 >90% or <70%) during the surgery. We will record PvO2 data in each patient.

Secondary outcomes

  1. The Precision of Fick-based Cardiac Output in Different FIO2 Groups during Cardiac Surgeries

    Time frame: 5 minutes before surgical incision

    After collecting the elements data included in the Fick eqaution (oxygen consumption, hemoglobin, SaO2, SvO2, PaO2, and PvO2), we can calculate the Fick-based cardiac output in each patient. And the pulmonary artery thermodilution is adopted as the standard cardiac output monitoring method. We will calculate the correlation and level of agreement between Fick-based cardiac output and pulmonary artery thermodilution in the two groups.

  2. The Precision of Fick-based Cardiac Output in Different FIO2 Groups during Cardiac Surgeries

    Time frame: 5 minutes after finishing protamine infusion

    After collecting the elements data included in the Fick eqaution (oxygen consumption, hemoglobin, SaO2, SvO2, PaO2, and PvO2), we can calculate the Fick-based cardiac output in each patient. And the pulmonary artery thermodilution is adopted as the standard cardiac output monitoring method. We will calculate the correlation and level of agreement between Fick-based cardiac output and pulmonary artery thermodilution in the two groups.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Increasing FIO2 Influences Accuracy of Fick-based Assessments of Cardiac Output in Cardiac Surgery Patients

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 3, 2019
Registry last updated
Jun 5, 2019

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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