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

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Unknown
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	1 Month - 12 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05699681
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Post Graduate Institute of Medical Education and Research, Chandigarh
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	India
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Hypertension

Arms & Interventions

Arms

: 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

Interventions

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.

Contact a Trial Team

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