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

NCT ID: NCT05699681

Last Updated: 2023-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-02-15

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Transthoracic and transesophageal echocardiography

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Measurement of Pulmonary arterial pressure

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role lead

Responsible Party

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Dr. Subhrashis Guha Niyogi

Principal Investigator, Division of Cardiac Anaesthesia, Department of Anaesthesia and Intensive Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Postgraduate Institute of Medical Education & Research

Chandigarh, , India

Site Status RECRUITING

Countries

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India

Central Contacts

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Subhrashis Guha Niyogi, DM

Role: CONTACT

9878687649

Facility Contacts

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Subhrashis Guha Niyogi, MBBS

Role: primary

+91 9878687649

Other Identifiers

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NK/6412/Study/494

Identifier Type: -

Identifier Source: org_study_id

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