Correlation of Right Atrial Strain With Pulmonary Hypertension, Right Ventricular Function And Outcome In Pediatric Patients

NCT05699681 | Unknown

• 1 other identifier: NK/6412/Study/494
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study aims to assess correlation of right atrial strain measured by two-dimensional speckle tracking echocardiography with intraoperatively measured pulmonary artery pressures, other indices of right ventricular function and short term postoperative outcome.

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• Correlation of right atrial strain measured by two-dimensional speckle tracking echocardiography with intraoperatively measured systolic pulmonary artery pressures.

  RA strain estimation will be done from the TTE images in RV focused A4C view, tracing the endocardial border from tricuspid annulus to tricuspid annulus along RA lateral wall to roof to septal wall. After optimizing the region of interest and automated speckle tracking for longitudinal strain and the following parameters will be measured : * RA reservoir strain : difference of the strain value at tricuspid valve opening minus ventricular end-diastole (positive value). * RA conduit strain : difference of the strain value at the onset of atrial contraction minus tricuspid valve opening (negative value). * RA contractile strain : difference of the strain value at ventricular end- diastole minus onset of atrial contraction (negative value).

  For RA strain : after induction of anesthesia, before CPB institution. For pulmonary artery pressures, after induction of anesthesia, before CPB institution, and 10 min after separation from CPB, before sternal closure.

Secondary Outcomes (2)

• Correlation of right atrial strain measured by two-dimensional speckle tracking echocardiography with other indices of right ventricular function.

  For RA strain and RV function : after induction of anesthesia, before CPB institution.

• Correlation of right atrial strain measured by two-dimensional speckle tracking echocardiography with short term postoperative outcome as defined by duration of mechanical ventilation and duration of ICU stay.

  Preoperative (post induction, pre-CPB) RA reservoir, conduit and contractile strain will be correlated with duration of mechanical ventilation, and duration of ICU stay, measured on 30 days post-operative follow up.

Study Arms (1)

Study cohort

Children aged below 12 years undergoing elective cardiac surgery for congenital heart disease with left to right shunt with prior evidence of pulmonary arterial hypertension on preoperative echocardiography

Diagnostic Test: Transthoracic and transesophageal echocardiography

Interventions

Transthoracic and transesophageal echocardiography DIAGNOSTIC_TEST

After induction of anaesthesia and stabilization of hemodynamics, transthoracic echocardiography will be done on a GE Vivid e9 workstation (GE Vingmed, Horton, Norway) with MS5 transthoracic probe with synchronized ECG. From TTE the following views and measurements will be acquired : * Apical four chamber (A4C) view * Apical two chamber view (A2C) view * Right ventricle (RV) focused A4C view * Right ventricular systolic pressure (RVSP) * Pulmonary arterial acceleration time (PAAT), * Tricuspid annular plane systolic excursion (TAPSE), * Tricuspid annular plane systolic velocity (s'), * Right ventricular fractional area change (RV FAC) * RV free wall strain, * RV myocardial performance index (MPI), * RV isovolumic relaxation time (IVRT), * RV isovolumic acceleration time (IVA) Invasive PA pressure measurement will be done after surgical exposure with a fine needle and a zeroed transducer by the Surgeon.

Also known as: Measurement of Pulmonary arterial pressure

Study cohort

Eligibility Criteria

• Age: 1 Month - 12 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

As described above.

You may qualify if:

• Undergoing elective cardiac surgery for congenital heart disease with left to right shunt
• Prior evidence of pulmonary arterial hypertension on preoperative echocardiography.

You may not qualify if:

• Neonates
• Children with history of previous cardiac surgery,
• Hemodynamic instability
• Non-sinus rhythm

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Postgraduate Institute of Medical Education & Research

Chandigarh, 160012, India

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Echocardiography, Transesophageal

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Echocardiography; Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Central Study Contacts

Subhrashis Guha Niyogi, DM

CONTACT

9878687649; 09renol@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Division of Cardiac Anaesthesia, Department of Anaesthesia and Intensive Care

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: January 26, 2023
• Study Start: January 1, 2021
• Primary Completion: January 31, 2023
• Study Completion: February 15, 2023
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)