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

January 22, 2023 updated by: Dr. Subhrashis Guha Niyogi, Postgraduate Institute of Medical Education and Research
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
      • Chandigarh, India, 160012
        • Recruiting
        • Postgraduate Institute of Medical Education & Research
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 12 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

As described above.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of right atrial strain measured by two-dimensional speckle tracking echocardiography with intraoperatively measured systolic pulmonary artery pressures.
Time Frame: 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).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of right atrial strain measured by two-dimensional speckle tracking echocardiography with other indices of right ventricular function.
Time Frame: 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)
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.
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Medical Education and Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Anticipated)

January 31, 2023

Study Completion (Anticipated)

February 15, 2023

Study Registration Dates

First Submitted

December 12, 2022

First Submitted That Met QC Criteria

January 22, 2023

First Posted (Actual)

January 26, 2023

Study Record Updates

Last Update Posted (Actual)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 22, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NK/6412/Study/494

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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