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出境医 / 临床实验 / FIO2 Influences Accuracy of Fick-based Cardiac Output
FIO2 Influences Accuracy of Fick-based Cardiac Output
Study Description
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cardiac Output | Other: fraction of inspired oxygen (FIO2) | Not Applicable |
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 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.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 24 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Other |
| Official Title: | Increasing FIO2 Influences Accuracy of Fick-based Assessments of Cardiac Output in Cardiac Surgery Patients |
| Actual Study Start Date : | January 1, 2015 |
| Actual Primary Completion Date : | January 1, 2017 |
| Actual Study Completion Date : | January 1, 2017 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: FIO2 >90% group
This group receives FIO2 >90% during the surgery.
|
Other: fraction of inspired oxygen (FIO2)
Different group receives different (70% vs. 90%) fraction of inspired oxygen (FIO2) during the surgery.
|
|
Active Comparator: FIO2 <70% group
This group receives FIO2 <70% during the surgery.
|
Other: fraction of inspired oxygen (FIO2)
Different group receives different (70% vs. 90%) fraction of inspired oxygen (FIO2) during the surgery.
|
Outcome Measures
Primary Outcome Measures :
- The Hemoglobin Values in Different FIO2 Groups during Cardiac Surgeries [ Time Frame: 5 minutes before surgical incision ]The patients were divided into two FIO2 groups (FIO2 >90% or <70%) during the surgery. We will collect hemoglobin data in each patient.
- The Hemoglobin Values in Different FIO2 Groups during Cardiac Surgeries [ Time Frame: 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 Oxygen Consumption in Different FIO2 Groups during Cardiac Surgeries [ Time Frame: 5 minutes before surgical incision ]The patients were divided into two FIO2 groups (FIO2 >90% or <70%) during the surgery. We will calculate oxygen consumption in each patient.
- The Oxygen Consumption in Different FIO2 Groups during Cardiac Surgeries [ Time Frame: 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 SaO2 in Different FIO2 Groups during Cardiac Surgeries [ Time Frame: 5 minutes before surgical incision ]The patients were divided into two FIO2 groups (FIO2 >90% or <70%) during the surgery. We will record SaO2 data in each patient.
- The SaO2 in Different FIO2 Groups during Cardiac Surgeries [ Time Frame: 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 [ Time Frame: 5 minutes before surgical incision ]The patients were divided into two FIO2 groups (FIO2 >90% or <70%) during the surgery. We will record SvO2 data in each patient.
- The SvO2 in Different FIO2 Groups during Cardiac Surgeries [ Time Frame: 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 [ Time Frame: 5 minutes before surgical incision ]The patients were divided into two FIO2 groups (FIO2 >90% or <70%) during the surgery. We will record PaO2 data in each patient.
- The PaO2 in Different FIO2 Groups during Cardiac Surgeries [ Time Frame: 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.
- The PvO2 in Different FIO2 Groups during Cardiac Surgeries [ Time Frame: 5 minutes before surgical incision ]The patients were divided into two FIO2 groups (FIO2 >90% or <70%) during the surgery. We will record PvO2 data in each patient.
- The PvO2 in Different FIO2 Groups during Cardiac Surgeries [ Time Frame: 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.
Secondary Outcome Measures :
- The Precision of Fick-based Cardiac Output in Different FIO2 Groups during Cardiac Surgeries [ Time Frame: 5 minutes before surgical incision ]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.
- The Precision of Fick-based Cardiac Output in Different FIO2 Groups during Cardiac Surgeries [ Time Frame: 5 minutes after finishing protamine infusion ]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.
Eligibility Criteria
| Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- undergoing planned elective cardiac surgery
- agree to sign informed consent
Exclusion Criteria:
- cardiac arrhythmia
- intra-cardiac shunt
Contacts and Locations
No Contacts or Locations Provided
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 20, 2019 | ||||
| First Posted Date ICMJE | June 3, 2019 | ||||
| Last Update Posted Date | June 5, 2019 | ||||
| Actual Study Start Date ICMJE | January 1, 2015 | ||||
| Actual Primary Completion Date | January 1, 2017 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | FIO2 Influences Accuracy of Fick-based Cardiac Output | ||||
| Official Title ICMJE | Increasing FIO2 Influences Accuracy of Fick-based Assessments of Cardiac Output in Cardiac Surgery Patients | ||||
| 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. | ||||
| 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 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Other |
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| Condition ICMJE | Cardiac Output | ||||
| Intervention ICMJE | Other: fraction of inspired oxygen (FIO2)
Different group receives different (70% vs. 90%) fraction of inspired oxygen (FIO2) during the surgery.
|
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
24 | ||||
| Original Actual Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | January 1, 2017 | ||||
| Actual Primary Completion Date | January 1, 2017 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 20 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03970980 | ||||
| Other Study ID Numbers ICMJE | 201900558B0 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Chang Gung Memorial Hospital | ||||
| Study Sponsor ICMJE | Chang Gung Memorial Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Chang Gung Memorial Hospital | ||||
| Verification Date | May 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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