FIO2 Influences SvO2 Interpretation and Fick-based Cardiac Output Assessment

Not Applicable

Completed

• Conditions: Cardiac Output

• Registration Number: NCT04265924
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-12-01
• Primary Completion: 2016-11-30
• Study Completion: 2016-11-30
• Status Verified: 2020-02
• Study First Submitted: 2020-02-09
• Study First Submitted QC: 2020-02-09
• Study First Posted: 2020-02-12
• Last Update Submitted: 2020-02-12
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

• intra-cardiac shunt

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The Hemoglobin Values in Different FIO2 Groups during Cardiac Surgeries	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.
The Oxygen Consumption in Different FIO2 Groups during Cardiac Surgeries	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.
The Blood PH Values in Different FIO2 Groups during Cardiac Surgeries	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.
The Body Temperatures in Different FIO2 Groups during Cardiac Surgeries	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.
The SaO2 in Different FIO2 Groups during Cardiac Surgeries	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.
The SvO2 in Different FIO2 Groups during Cardiac Surgeries	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.
The PaO2 in Different FIO2 Groups during Cardiac Surgeries	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.
The PvO2 in Different FIO2 Groups during Cardiac Surgeries	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 Outcome Measures

Name	Time	Method
The Precision of Fick-based Cardiac Output in Different FIO2 Groups during Cardiac Surgeries	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.