FIO2 Influences SvO2 Interpretation and Fick-based Cardiac Output Assessment

• Sponsor: Chang Gung Memorial Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04265924
• Collaborator: (none)
• Enrollment: 50
• Arms: 2
• Actual Duration (Months): 12

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Output	Other: fraction of inspired oxygen (FIO2)	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Increased FIO2 Influences SvO2 Interpretation and Accuracy of Fick-based Cardiac Output Assessment in Cardiac Surgery Patients
• Actual Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Nov 30, 2016
• Actual Study Completion Date: Nov 30, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: >0.85 FIO2 group This group receives FIO2 >0.85 during the surgery.	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.
Active Comparator: <0.7 FIO2 group This group receives FIO2 <0.7 during the surgery.	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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• undergoing planned elective cardiac surgery

• agree to sign informed consent

Exclusion Criteria:

• intra-cardiac shunt

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Chang Gung Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chang Gung Memorial Hospital
• ClinicalTrials.gov Identifier: NCT04265924
• Other Study ID Numbers: 104-7177B
• First Posted: Feb 12, 2020
• Last Update Posted: Feb 17, 2020
• Last Verified: Feb 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Feb 17, 2020