- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02534103
Relationship Between a Combined Index of Diastolic and Systolic Performance and Intraoperative Hemodynamic Changes During Off-pump Coronary Bypass Surgery
As considering the close relationship between systolic dysfunction and diastolic dysfunction, the EAS index e'/(a' x s') including systolic and diastolic function could be expected to predict hemodynamic changes during off-pump coronary artery bypass surgery(OPCAB). Exposure of the grafting site during OPCAB needs displacement of the heart, resulting in hemodynamic instability.
Therefore the investigators are going to evaluate EAS index with preoperative Transthoracic echocardiography(TTE) and want to know the relationship between preoperative EAS index and intraoperative hemodynamic changes in patients undergoing OPCAB, in a prospective observational study.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Seoul, Korea, Republic of, 120-752
- Department of Anaesthesiology and Pain Medicine, Yonsei University College of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥ 20
- Patients undergoing multivessel off-pump coronary artery bypass surgery
Exclusion Criteria:
- Age < 20
- Patients with valvular heart disease
- Congestive heart failure, NYHA class ≥III
- Emergency surgery
- Patients with arrhythmia
- ST segment elevation myocardial infarction
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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sequential changes of SvO2
Time Frame: during OPCAB surgery
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Mixed venous oxygen saturation(SvO2) reflects the balance of oxygen supply and demand immediately.
Cardiac index(CI) also is a useful marker of how well the heart is functioning.
Both variables can show the hemodynamic instability.
With the comparison of EAS index and variables including SvO2 and CI, Investigator may draw the predictable value of the EAS index for predicting hemodynamic instability during OPCAB.
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during OPCAB surgery
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sequential changes of CI
Time Frame: during OPCAB surgery
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during OPCAB surgery
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jae-Kwang Shim, MD, PhD, Severance Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 4-2014-0879
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