Relationship Between Strain and Stroke Volume in Cardiac Surgery

Completed

• Conditions: Right Ventricular Dysfunction; Stroke Volume Index; Longitudinal Heart Strain

• Registration Number: NCT04694378
• Lead Sponsor: Tufts Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2020-12-16
• Study First Submitted QC: 2021-01-02
• Study First Posted: 2021-01-05
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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

Name	Time	Method
Change in cardiac output measured with Swan-Ganz during CABG	during CABG surgery	Cardiac output (L/min) measured with the thermodilution technique

Trial Locations

Locations (1)

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States