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NCT Number: NCT04265924

FIO2 Influences SvO2 Interpretation and Fick-based Cardiac Output Assessment

In this study, the investigators sought to clarify the influence of FIO2 levels on the variables in the Fick equation and then assessed the influence of each variable on the accuracy of Fick-CO measurements in patients undergoing cardiac surgery.

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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 an intra-cardiac shunt are excluded.

The patients are randomly assigned to 2 groups: FIO2 <0.7 or FIO2 >0.85. And during the surgery, the oximeter values are kept ≥98%. Intra-operatively, FIO2, PaO2, SaO2, SvO2, PvO2, Hb, blood pH values, body temperature 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

  • intra-cardiac shunt

Treatment and study plan

fraction of inspired oxygen (FIO2)

Other

The fraction of inspired oxygen (FIO2) is given accordingly (>0.85 for the >0.85 group, and <0.7 for the <0.7 group) to the patients during the surgery.

Primary outcomes

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

    Time frame: under general anesthesia but before surgical incision

    The patients were divided into two FIO2 groups (FIO2 >0.85 or <0.7) during the surgery. We will collect hemoglobin data in each patient.

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

    Time frame: under general anesthesia but before surgical incision

    The patients were divided into two FIO2 groups (FIO2 >0.85 or <0.7) during the surgery. We will use the LaFarge equation to calculate oxygen consumption (ml/min/m^2) in each patient.

  3. The Blood PH Values in Different FIO2 Groups during Cardiac Surgeries

    Time frame: under general anesthesia but before surgical incision

    The patients were divided into two FIO2 groups (FIO2 >0.85 or <0.7) during the surgery. We will calculate oxygen consumption in each patient.

  4. The Body Temperatures in Different FIO2 Groups during Cardiac Surgeries

    Time frame: under general anesthesia but before surgical incision

    The patients were divided into two FIO2 groups (FIO2 >0.85 or <0.7) during the surgery. We will calculate oxygen consumption in each patient.

  5. The SaO2 in Different FIO2 Groups during Cardiac Surgeries

    Time frame: under general anesthesia but before surgical incision

    The patients were divided into two FIO2 groups (FIO2 >0.85 or <0.7) during the surgery. We will calculate oxygen consumption in each patient.

  6. The SvO2 in Different FIO2 Groups during Cardiac Surgeries

    Time frame: under general anesthesia but before surgical incision

    The patients were divided into two FIO2 groups (FIO2 >0.85 or <0.7) during the surgery. We will calculate oxygen consumption in each patient.

  7. The PaO2 in Different FIO2 Groups during Cardiac Surgeries

    Time frame: under general anesthesia but before surgical incision

    The patients were divided into two FIO2 groups (FIO2 >0.85 or <0.7) during the surgery. We will calculate oxygen consumption in each patient.

  8. The PvO2 in Different FIO2 Groups during Cardiac Surgeries

    Time frame: under general anesthesia but before surgical incision

    The patients were divided into two FIO2 groups (FIO2 >0.85 or <0.7) during the surgery. We will calculate oxygen consumption in each patient.

Secondary outcomes

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

    Time frame: under general anesthesia but 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.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Increased FIO2 Influences SvO2 Interpretation and Accuracy of Fick-based Cardiac Output Assessment in Cardiac Surgery Patients

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 12, 2020
Registry last updated
Feb 17, 2020

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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