FIO2 Influences SvO2 Interpretation and Fick-based Cardiac Output Assessment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-01

Study Completion Date

2016-11-30

Brief Summary

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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.

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Shock

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Detailed Description

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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.

Conditions

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Cardiac Output

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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>0.85 FIO2 group

This group receives FIO2 \>0.85 during the surgery.

Group Type ACTIVE_COMPARATOR

fraction of inspired oxygen (FIO2)

Intervention Type OTHER

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.

<0.7 FIO2 group

This group receives FIO2 \<0.7 during the surgery.

Group Type ACTIVE_COMPARATOR

fraction of inspired oxygen (FIO2)

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER