Cardiac OutputNCT04265924
FIO2 Influences SvO2 Interpretation and Fick-based Cardiac Output Assessment
A study testing fraction of inspired oxygen (FIO2) in people with Cardiac Output, run by Chang Gung Memorial Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cardiac Output
- What is being tested?
- fraction of inspired oxygen (FIO2)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2015to 30 Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing planned elective cardiac surgery
- agree to sign informed consent
Who cannot join
- intra-cardiac shunt
About this study
Official title: Increased FIO2 Influences SvO2 Interpretation and Accuracy of Fick-based Cardiac Output Assessment in Cardiac Surgery Patients
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.
Read the 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.
- Conditions
- Cardiac Output
- Being tested
- fraction of inspired oxygen (FIO2)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| >0.85 FIO2 group | Active comparator | This group receives FIO2 >0.85 during the surgery. Receives: Other: fraction of inspired oxygen (FIO2) |
| <0.7 FIO2 group | Active comparator | This group receives FIO2 <0.7 during the surgery. Receives: Other: fraction of inspired oxygen (FIO2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: under general anesthesia but before surgical incision
Secondary outcomes (1)
The Precision of Fick-based Cardiac Output in Different FIO2 Groups during Cardiac Surgeries
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.
Measured: under general anesthesia but before surgical incision
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start1 Dec 2015
- Primary completion30 Nov 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac OutputStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265924
- Sponsor's protocol ID
- 104-7177B
- Status last verified
- Feb 2020
- First submitted
- 9 Feb 2020
- Last updated
- 17 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34516492
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increased FIO2 Influences SvO2 Interpretation and Accuracy of Fick-based Cardiac Output Assessment in Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT04265924
- Acronym / sponsor ID
- 104-7177B
- Conditions
- Cardiac Output
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 12 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| >0.85 FIO2 group | Active comparator | Other: fraction of inspired oxygen (FIO2)This group receives FIO2 >0.85 during the surgery. |
| <0.7 FIO2 group | Active comparator | Other: fraction of inspired oxygen (FIO2)This group receives FIO2 <0.7 during the surgery. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- undergoing planned elective cardiac surgery
- agree to sign informed consent
Key exclusion criteria (1 listed)
- intra-cardiac shunt
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | <0.7 FIO2 group, >0.85 FIO2 group |
Primary outcome
The Hemoglobin Values in Different FIO2 Groups during Cardiac Surgeries
Time frame: 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.
The Oxygen Consumption in Different FIO2 Groups during Cardiac Surgeries
Time frame: 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.
The Blood PH Values in Different FIO2 Groups during Cardiac Surgeries
Time frame: 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.
The Body Temperatures in Different FIO2 Groups during Cardiac Surgeries
Time frame: 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.
The SaO2 in Different FIO2 Groups during Cardiac Surgeries
Time frame: 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.
The SvO2 in Different FIO2 Groups during Cardiac Surgeries
Time frame: 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.
The PaO2 in Different FIO2 Groups during Cardiac Surgeries
Time frame: 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.
The PvO2 in Different FIO2 Groups during Cardiac Surgeries
Time frame: 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.
1 secondary outcome
The Precision of Fick-based Cardiac Output in Different FIO2 Groups during Cardiac Surgeries
Time frame: under general anesthesia but before surgical incision
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Derived from this study: PubMed 34516492Lin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing fraction of inspired oxygen (FIO2) in people with Cardiac Output, run by Chang Gung Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Hemoglobin Values in Different FIO2 Groups during Cardiac Surgeries (time frame: under general anesthesia but before surgical incision). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04265924, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.