Echocardiography Findings and Perioperative Outcomes in Children

Echocardiography Findings and Perioperative Outcomes in Children Undergoing Congenital Heart Surgery: Prospective Observational Study

This study evaluates the association between perioperative echocardiographic Doppler findings and clinical outcomes in pediatric patients undergoing cardiac surgery. In our center, anesthesiologists perform transthoracic or transesophageal echocardiography during perioperative period routinely in children undergoing surgery for congenital cardiac disease. Echocardiographic findings include the doppler patterns of hepatic vein, portal vein, renal artery, renal vein and splenic vein before and after cardiopulmonary bypass. Portal pulsatility index, renal resistive index, and respiratory variations in peak aortic blood flow velocity and diameter of inferior vena cava are measured.

Study Overview

• Status: Completed
• Conditions: Congenital Cardiac Defect
• Intervention / Treatment: Diagnostic test: Echocardiography

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Pediatric patients undergoing cardiac surgery

Description

Inclusion Criteria:

• All pediatric patients undergoing cardiac surgery

Exclusion Criteria:

• Applying extracorporeal membrane oxygenator prior to surgery
• Trouble applying echocardiography

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Children with congenital cardiac disease; Children with congenital cardiac disease who undergoing surgery	Diagnostic test: Echocardiography; Echocardiographic examination before and after cardiopulmonary bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characteristics of Doppler values and its derived parameters of portal vein, hepatic vein, renal artery and vein, and splenic vein measured using echocardiography in children with congenital cardiac disease	To find the characteristics and standard values of Doppler findings measured by echocardiography before and after congenital cardiac surgery	after anesthetic induction until the end of surgery
Association between Doppler values measured by echocardiography and clinical outcomes after pediatric cardiac surgery	To evaluate whether Doppler values of portal vein, hepatic vein, renal artery and vein, and splenic vein measured using echocardiography can predict major adverse outcomes after pediatric cardiac surgery	through study completion, an average 1-2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of patients with major adverse outcomes after pediatric cardiac surgery	through study completion, an average 1-2 years

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2019
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: June 14, 2019
• First Submitted That Met QC Criteria: June 17, 2019
• First Posted (Actual): June 19, 2019

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital
• Other Study ID Numbers: H1906-031-1038

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No