FIO2 Influences SvO2 Interpretation and Fick-based Cardiac Output Assessment

Cardiac Output Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04265924
• Other study ID #: 104-7177B
• Status: Completed
• Phase: N/A
• Start date: December 1, 2015
• Est. completion date: November 30, 2016

Study information

• Verified date: February 2020
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 30, 2016
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• undergoing planned elective cardiac surgery

• agree to sign informed consent

Exclusion Criteria:

• intra-cardiac shunt

Related Conditions & MeSH terms

• Cardiac Output

Intervention

Other:
• fraction of inspired oxygen (FIO2)
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Hemoglobin Values in Different FIO2 Groups during Cardiac Surgeries	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.	under general anesthesia but before surgical incision
Primary	The Oxygen Consumption in Different FIO2 Groups during Cardiac Surgeries	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.	under general anesthesia but before surgical incision
Primary	The Blood PH Values in Different FIO2 Groups during Cardiac Surgeries	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.	under general anesthesia but before surgical incision
Primary	The Body Temperatures in Different FIO2 Groups during Cardiac Surgeries	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.	under general anesthesia but before surgical incision
Primary	The SaO2 in Different FIO2 Groups during Cardiac Surgeries	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.	under general anesthesia but before surgical incision
Primary	The SvO2 in Different FIO2 Groups during Cardiac Surgeries	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.	under general anesthesia but before surgical incision
Primary	The PaO2 in Different FIO2 Groups during Cardiac Surgeries	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.	under general anesthesia but before surgical incision
Primary	The PvO2 in Different FIO2 Groups during Cardiac Surgeries	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.	under general anesthesia but before surgical incision
Secondary	The Precision of Fick-based Cardiac Output in Different FIO2 Groups during Cardiac Surgeries	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.	under general anesthesia but before surgical incision