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Relationship Between a Combined Index of Diastolic and Systolic Performance and Intraoperative Hemodynamic Changes During Off-pump Coronary Bypass Surgery

Sponsor
Yonsei University (Other)
Overall Status
Completed
CT.gov ID
NCT02534103
Collaborator
(none)
120
Enrollment
1
Location
22.2
Duration (Months)
5.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    120 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Study Start Date :
    Aug 4, 2015
    Actual Primary Completion Date :
    Jun 9, 2017
    Actual Study Completion Date :
    Jun 9, 2017

    Outcome Measures

    Primary Outcome Measures

    1. sequential changes of SvO2 [during OPCAB surgery]

      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.

    2. sequential changes of CI [during OPCAB surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Age ≥ 20

    2. Patients undergoing multivessel off-pump coronary artery bypass surgery

    Exclusion Criteria:

    1. Age < 20

    2. Patients with valvular heart disease

    3. Congestive heart failure, NYHA class ≥III

    4. Emergency surgery

    5. Patients with arrhythmia

    6. ST segment elevation myocardial infarction

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Anaesthesiology and Pain Medicine, Yonsei University College of Medicine Seoul Korea, Republic of 120-752

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    • Principal Investigator: Jae-Kwang Shim, MD, PhD, Severance Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yonsei University
    ClinicalTrials.gov Identifier:
    NCT02534103
    Other Study ID Numbers:
    • 4-2014-0879
    First Posted:
    Aug 27, 2015
    Last Update Posted:
    Aug 7, 2020
    Last Verified:
    Aug 1, 2020

    Study Results

    No Results Posted as of Aug 7, 2020