FIO2 Influences Accuracy of Fick-based Cardiac Output

NCT03970980 | Completed

• 1 other identifier: 201900558B0
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

Cardiac output (CO) monitoring is often required for clinical evaluation and management in critically ill patients and during anesthesia. There are many methods to measure CO. Fick-based CO estimation (Fick-CO) is one of the most commonly used methods, while thermodilution (TD-CO) is viewed as golden standard. But Fick-CO is still widely used, especially in catheterization laboratories and pediatric cardiologic department, whose patients often with congenital heart disease. Multiple studies from the 1960s find a strong correlation between TD-CO and Fick-CO. However, more recent studies reject the conclusion. Since Fick-CO is the ratio of oxygen consumption (V'O2) to the arteriovenous difference in oxygen content, many parameters are included in the Fick equation, such as V'O2, hemoglobin (Hb), arterial oxygen saturation (SaO2), mixed venous oxygen saturation (SvO2), partial pressure of arterial oxygen (PaO2), and mixed venous oxygen tension (PvO2). Any changes of each parameter may influence the accuracy of Fick-CO calculation. This may be the reason why it remains controversial whether Fick-CO and TD-CO are interchangeable or not. Although there are lots of studies comparing Fick-CO and TD-CO, discussing the impact of V'O2 on Fick-CO, how the other parameters influence the final CO estimation are rarely focused. Therefore, the purpose of this study was to assess the influence of FIO2 on PaO2, SvO2, PvO2, and the accuracy of Fick-CO in cardiac surgery patients.

Conditions

Cardiac Output

Keywords

Fick Principle

Outcome Measures

Primary Outcomes (12)

• The Hemoglobin Values in Different FIO2 Groups during Cardiac Surgeries

  The patients were divided into two FIO2 groups (FIO2 \>90% or \<70%) during the surgery. We will collect hemoglobin data in each patient.

  5 minutes before surgical incision

• The Hemoglobin Values in Different FIO2 Groups during Cardiac Surgeries

  The patients were divided into two FIO2 groups (FIO2 \>90% or \<70%) during the surgery. We will collect hemoglobin data in each patient.

  5 minutes after finishing protamine infusion

• The Oxygen Consumption in Different FIO2 Groups during Cardiac Surgeries

  The patients were divided into two FIO2 groups (FIO2 \>90% or \<70%) during the surgery. We will calculate oxygen consumption in each patient.

  5 minutes before surgical incision

• The Oxygen Consumption in Different FIO2 Groups during Cardiac Surgeries

  The patients were divided into two FIO2 groups (FIO2 \>90% or \<70%) during the surgery. We will calculate oxygen consumption in each patient.

  5 minutes after finishing protamine infusion

• The SaO2 in Different FIO2 Groups during Cardiac Surgeries

  The patients were divided into two FIO2 groups (FIO2 \>90% or \<70%) during the surgery. We will record SaO2 data in each patient.

  5 minutes before surgical incision

• The SaO2 in Different FIO2 Groups during Cardiac Surgeries

  The patients were divided into two FIO2 groups (FIO2 \>90% or \<70%) during the surgery. We will record SaO2 data in each patient.

  5 minutes after finishing protamine infusion

• The SvO2 in Different FIO2 Groups during Cardiac Surgeries

  The patients were divided into two FIO2 groups (FIO2 \>90% or \<70%) during the surgery. We will record SvO2 data in each patient.

  5 minutes before surgical incision

• The SvO2 in Different FIO2 Groups during Cardiac Surgeries

  The patients were divided into two FIO2 groups (FIO2 \>90% or \<70%) during the surgery. We will record SvO2 data in each patient.

  5 minutes after finishing protamine infusion

• The PaO2 in Different FIO2 Groups during Cardiac Surgeries

  The patients were divided into two FIO2 groups (FIO2 \>90% or \<70%) during the surgery. We will record PaO2 data in each patient.

  5 minutes before surgical incision

• The PaO2 in Different FIO2 Groups during Cardiac Surgeries

  The patients were divided into two FIO2 groups (FIO2 \>90% or \<70%) during the surgery. We will record PaO2 data in each patient.

  5 minutes after finishing protamine infusion

• The PvO2 in Different FIO2 Groups during Cardiac Surgeries

  The patients were divided into two FIO2 groups (FIO2 \>90% or \<70%) during the surgery. We will record PvO2 data in each patient.

  5 minutes before surgical incision

• The PvO2 in Different FIO2 Groups during Cardiac Surgeries

  The patients were divided into two FIO2 groups (FIO2 \>90% or \<70%) during the surgery. We will record PvO2 data in each patient.

  5 minutes after finishing protamine infusion

Secondary Outcomes (2)

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

  5 minutes before surgical incision

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

  5 minutes after finishing protamine infusion

Study Arms (2)

FIO2 >90% group

EXPERIMENTAL

This group receives FIO2 \>90% during the surgery.

Other: fraction of inspired oxygen (FIO2)

FIO2 <70% group

ACTIVE COMPARATOR

This group receives FIO2 \<70% during the surgery.

Other: fraction of inspired oxygen (FIO2)

Interventions

fraction of inspired oxygen (FIO2) OTHER

Different group receives different (70% vs. 90%) fraction of inspired oxygen (FIO2) during the surgery.

FIO2 <70% group; FIO2 >90% group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• cardiac arrhythmia
• intra-cardiac shunt

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: June 3, 2019
• Study Start: January 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: June 5, 2019

Record last verified: 2019-05