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

Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05699681
• Other study ID #: NK/6412/Study/494
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: February 15, 2023

Study information

• Verified date: January 2023
• Source: Postgraduate Institute of Medical Education and Research
• Contact: Subhrashis Guha Niyogi, DM
• Phone: 9878687649
• Email: 09renol[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 15, 2023
• Est. primary completion date: January 31, 2023
• Gender: All
• Age group: 1 Month to 12 Years

Eligibility

Inclusion Criteria:

• Undergoing elective cardiac surgery for congenital heart disease with left to right shunt

• Prior evidence of pulmonary arterial hypertension on preoperative echocardiography.

Exclusion Criteria:

• Neonates

• Children with history of previous cardiac surgery,

• Hemodynamic instability

• Non-sinus rhythm

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Diagnostic Test:
• Transthoracic and transesophageal echocardiography
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.

Locations

Country	Name	City	State
India	Postgraduate Institute of Medical Education & Research	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Correlation of right atrial strain measured by two-dimensional speckle tracking echocardiography with other indices of right ventricular function.	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)	For RA strain and RV function : after induction of anesthesia, before CPB institution.
Secondary	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.	Duration of mechanical ventilation will be measured from time of shifting out from the operating room to first extubation. Similarly, ICU stay will be measured from the date of surgery to shifting to general ward.	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.