Relationship Between Strain and Stroke Volume in Cardiac Surgery

Right Ventricular Dysfunction Clinical Trial

Official title:

Relationship Between Right Ventricular Free Wall Longitudinal Strain and Stroke Volume Index by Thermodilution in Patients Undergoing Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04694378
• Other study ID #: 1
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: November 1, 2022

Study information

• Verified date: April 2024
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Longitudinal Heart Strain
• Right Ventricular Dysfunction
• Sprains and Strains
• Stroke
• Stroke Volume Index
• Ventricular Dysfunction
• Ventricular Dysfunction, Right

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of right ventricular function during CABG assessed by right heart strain (%)	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.	during CABG surgery
Primary	Change of right ventricular function during CABG assessed by stroke volume index (mL/m2)	Assessing the change of RV function during CABG surgery using stroke volume index. Stroke volume index measurement as millilitres per square meter (ml/m2)	during CABG surgery
Secondary	Change in cardiac output measured with Swan-Ganz during CABG	Cardiac output (L/min) measured with the thermodilution technique	during CABG surgery