跳至主要内容
临床试验/NCT03970980
NCT03970980已完成不适用

Increasing FIO2 Influences Accuracy of Fick-based Assessments of Cardiac Output in Cardiac Surgery Patients

Chang Gung Memorial Hospital0 个研究点目标入组 24 人开始时间: 2015年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
主要终点
The Oxygen Consumption in Different FIO2 Groups during Cardiac Surgeries

研究概览

简要总结

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.

详细描述

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 cardiac arrhythmia or an intra-cardiac shunt are excluded.

The patients are randomly assigned to 2 groups: FIO2 <70% or FIO2 >90%. And during the surgery, the oximeter values are kept ≥98%. Intra-operatively, FIO2, PaO2, SvO2, PvO2, Hb, and TD-CO are recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • cardiac arrhythmia
  • intra-cardiac shunt

研究组 & 干预措施

FIO2 >90% group

Experimental

This group receives FIO2 >90% during the surgery.

干预措施: fraction of inspired oxygen (FIO2) (Other)

FIO2 <70% group

Active Comparator

This group receives FIO2 <70% during the surgery.

干预措施: fraction of inspired oxygen (FIO2) (Other)

结局指标

主要结局

The Oxygen Consumption in Different FIO2 Groups during Cardiac Surgeries

时间窗: 5 minutes after finishing protamine infusion

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

The PvO2 in Different FIO2 Groups during Cardiac Surgeries

时间窗: 5 minutes after finishing protamine infusion

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

The Hemoglobin Values in Different FIO2 Groups during Cardiac Surgeries

时间窗: 5 minutes after finishing protamine infusion

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

The SaO2 in Different FIO2 Groups during Cardiac Surgeries

时间窗: 5 minutes after finishing protamine infusion

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

The SvO2 in Different FIO2 Groups during Cardiac Surgeries

时间窗: 5 minutes after finishing protamine infusion

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

The PaO2 in Different FIO2 Groups during Cardiac Surgeries

时间窗: 5 minutes after finishing protamine infusion

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

次要结局

  • The Precision of Fick-based Cardiac Output in Different FIO2 Groups during Cardiac Surgeries(5 minutes after finishing protamine infusion)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

相似试验