Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04694378
Other study ID # 1
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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).

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT03183414 - Right Ventricular Dysfunction in Cardiac Surgery Patients
Recruiting NCT04764032 - Right Ventricular Dysfunction in Ventilated Patients With COVID-19
Not yet recruiting NCT05188222 - Preoperative Maltodextrin's Effect on Cardiac Function in Cardiac Surgery Phase 4
Not yet recruiting NCT06002321 - Right Ventricular Dysfunction in Chronic Heart Failure
Completed NCT05948332 - Definition and Management of Right Ventricular Injury in Adult Patients Receiving Extracorporeal Membrane Oxygenation
Recruiting NCT03309852 - Emergency Department Assessment of Right Ventricular Function and Size in the Post Cardiac Arrest Patient
Recruiting NCT05583461 - Ventilator-induced Right Ventricular Injury During EIT-based PEEP Titration in Patients With ARDS N/A
Completed NCT03438825 - PRediction of Early PostoperAtive Right vEntricular Failure in Mitral Valve Replacement/Repair Patients
Active, not recruiting NCT01230294 - New Echocardiographic Methods for Right Ventricular Function. N/A
Completed NCT00557934 - Right Ventricular Contractility Reserve Following Repair of Tetralogy of Fallot N/A
Not yet recruiting NCT04167241 - Right Ventricle Function After Major Right Lung Resection
Recruiting NCT03013075 - General Plus Spinal Anesthesia and General Anesthesia Alone on Right Ventricular Function Phase 4
Completed NCT06197256 - Cardiac Dysfunction in Critically Ill Covid-19 Patients
Completed NCT03301571 - Right Ventricular Echocardiography in caRdiac SurgEry N/A
Recruiting NCT05860504 - Acute Cardiac Dysfunction in Critical Illnes
Completed NCT01093001 - Tricuspid Regurgitation Study Phase 4
Recruiting NCT05758194 - Mitigating Post-Op RV Dysfunction After LVAD Implantation N/A
Not yet recruiting NCT05768230 - Using TEE to Evaluate the Effect of Levosimendan on Patients With ARDS Associated With RVD During MV Phase 2/Phase 3
Not yet recruiting NCT05620992 - Evaluation of Right Ventricular Function Post Mitral Valve Operations
Completed NCT03806582 - Effect of a Higher Blood-pressure on Right Ventricular Function Phase 4