NCT04265924

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2016

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 12, 2020

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

1 year

First QC Date

February 9, 2020

Last Update Submit

February 12, 2020

Conditions

Cardiac Output

Outcome Measures

Primary Outcomes (8)

  • The Hemoglobin Values in Different FIO2 Groups during Cardiac Surgeries

    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.

    under general anesthesia but before surgical incision

  • The Oxygen Consumption in Different FIO2 Groups during Cardiac Surgeries

    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.

    under general anesthesia but before surgical incision

  • The Blood PH Values in Different FIO2 Groups during Cardiac Surgeries

    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.

    under general anesthesia but before surgical incision

  • The Body Temperatures in Different FIO2 Groups during Cardiac Surgeries

    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.

    under general anesthesia but before surgical incision

  • The SaO2 in Different FIO2 Groups during Cardiac Surgeries

    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.

    under general anesthesia but before surgical incision

  • The SvO2 in Different FIO2 Groups during Cardiac Surgeries

    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.

    under general anesthesia but before surgical incision

  • The PaO2 in Different FIO2 Groups during Cardiac Surgeries

    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.

    under general anesthesia but before surgical incision

  • The PvO2 in Different FIO2 Groups during Cardiac Surgeries

    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.

    under general anesthesia but before surgical incision

Secondary Outcomes (1)

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

    under general anesthesia but before surgical incision

Study Arms (2)

>0.85 FIO2 group

ACTIVE COMPARATOR

This group receives FIO2 \>0.85 during the surgery.

Other: fraction of inspired oxygen (FIO2)

<0.7 FIO2 group

ACTIVE COMPARATOR

This group receives FIO2 \<0.7 during the surgery.

Other: fraction of inspired oxygen (FIO2)

Interventions

fraction of inspired oxygen (FIO2)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>0.85 FIO2 group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • intra-cardiac shunt

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 34516492DERIVED

Study Design

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

Study Record Dates

First Submitted

February 9, 2020

First Posted

February 12, 2020

Study Start

December 1, 2015

Primary Completion

November 30, 2016

Study Completion

November 30, 2016

Last Updated

February 17, 2020

Record last verified: 2020-02