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

Sponsor
Postgraduate Institute of Medical Education and Research (Other)
Overall Status
Recruiting
CT.gov ID
NCT05699681
Collaborator
(none)
50
1
25.5
2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Transthoracic and transesophageal echocardiography

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Correlation of Right Atrial Strain With Pulmonary Hypertension, Right Ventricular Function And Outcome In Pediatric Patients
Actual Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Jan 31, 2023
Anticipated Study Completion Date :
Feb 15, 2023

Arms and Interventions

Arm Intervention/Treatment
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
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.
Other Names:
  • Measurement of Pulmonary arterial pressure
  • Outcome Measures

    Primary Outcome Measures

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

      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).

    Secondary Outcome Measures

    1. 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.]

      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)

    2. 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.]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month to 12 Years
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Postgraduate Institute of Medical Education & Research Chandigarh India 160012

    Sponsors and Collaborators

    • Postgraduate Institute of Medical Education and Research

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Subhrashis Guha Niyogi, Principal Investigator, Division of Cardiac Anaesthesia, Department of Anaesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research
    ClinicalTrials.gov Identifier:
    NCT05699681
    Other Study ID Numbers:
    • NK/6412/Study/494
    First Posted:
    Jan 26, 2023
    Last Update Posted:
    Jan 26, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 26, 2023