Clinical trial NCT04265924: FIO2 Influences SvO2 Interpretation and Fick-based Cardiac Output Assessment
Official title: Increased FIO2 Influences SvO2 Interpretation and Accuracy of Fick-based Cardiac Output Assessment in Cardiac Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Output
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-02-12
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* intra-cardiac shunt

Primary outcomes:
measure: The Hemoglobin Values in Different FIO2 Groups during Cardiac Surgeries
timeFrame: under general anesthesia but before surgical incision
measure: The Oxygen Consumption in Different FIO2 Groups during Cardiac Surgeries
timeFrame: under general anesthesia but before surgical incision
measure: The Blood PH Values in Different FIO2 Groups during Cardiac Surgeries
timeFrame: under general anesthesia but before surgical incision
measure: The Body Temperatures in Different FIO2 Groups during Cardiac Surgeries
timeFrame: under general anesthesia but before surgical incision
measure: The SaO2 in Different FIO2 Groups during Cardiac Surgeries
timeFrame: under general anesthesia but before surgical incision
measure: The SvO2 in Different FIO2 Groups during Cardiac Surgeries
timeFrame: under general anesthesia but before surgical incision
measure: The PaO2 in Different FIO2 Groups during Cardiac Surgeries
timeFrame: under general anesthesia but before surgical incision
measure: The PvO2 in Different FIO2 Groups during Cardiac Surgeries
timeFrame: under general anesthesia but before surgical incision
Secondary outcomes:
measure: The Precision of Fick-based Cardiac Output in Different FIO2 Groups during Cardiac Surgeries
timeFrame: under general anesthesia but before surgical incision
Other outcomes:
Locations:
Study officials:
References:
citation: Lin SY, Chang FC, Lin JR, Chou AH, Tsai YF, Liao CC, Tsai HI, Chen CY. Increased FIO2 influences SvO2 interpretation and accuracy of Fick-based cardiac output assessment in cardiac surgery patients: A prospective randomized study. Medicine (Baltimore). 2021 Sep 10;100(36):e27020. doi: 10.1097/MD.0000000000027020.