Relationship Between Strain and Stroke Volume in Cardiac Surgery

Sponsor
Tufts Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04694378
Collaborator
(none)
50
1
25
2

Study Details

Study Description

Brief Summary

Patients undergoing coronary artery bypass grafting up tp 30% will develop postoperative right ventricle dysfunction. Its imperative for the physician to fully understand the severity of this complication in order to perform an early diagnosis and carry out the appropriate treatment.

Aim:

Investigate the correlation between echocardiographic measurements and hemodynamic changes at different time points in patients undergoing coronary artery bypass graft surgery

Hypothesis:
  1. Weak correlation between echocardiographic measurements and hemodynamic changes during coronary artery bypass graft surgery

  2. Echocardiographic measurements would change across different time points during surgery independent of hemodynamic values.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Relationship Between Right Ventricular Free Wall Longitudinal Strain and Stroke Volume Index by Thermodilution in Patients Undergoing Cardiac Surgery
    Actual Study Start Date :
    Oct 1, 2020
    Anticipated Primary Completion Date :
    Jul 1, 2022
    Anticipated Study Completion Date :
    Oct 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Change of right ventricular function during CABG assessed by right heart strain (%) [during CABG surgery]

      Assessing the change of RV function during CABG surgery using right heart strain as a percentage of change between RV shortening and RV end diastolic length.

    2. Change of right ventricular function during CABG assessed by stroke volume index (mL/m2) [during CABG surgery]

      Assessing the change of RV function during CABG surgery using stroke volume index. Stroke volume index measurement as millilitres per square meter (ml/m2)

    Secondary Outcome Measures

    1. Change in cardiac output measured with Swan-Ganz during CABG [during CABG surgery]

      Cardiac output (L/min) measured with the thermodilution technique

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Elective coronary artery bypass graft patients who require pulmonary catheter placement for intraoperative monitoring.
    Exclusion Criteria:
    • Patients with contraindication to Swan-Ganz catheter placement,

    • Pre-existing atrial arrhythmias,

    • Patients with moderate and/or severe mitral/tricuspid valve stenosis or regurgitation

    • Patients with contraindication to transesophageal echocardiogram probe placement (i.e. esophageal stenosis).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tufts Medical Center Boston Massachusetts United States 06111

    Sponsors and Collaborators

    • Tufts Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tufts Medical Center
    ClinicalTrials.gov Identifier:
    NCT04694378
    Other Study ID Numbers:
    • 1
    First Posted:
    Jan 5, 2021
    Last Update Posted:
    Nov 15, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Tufts Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 15, 2021