Summary

Eligibility
for people ages up to 21 years (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

Summary

The incidence of moderate to severe congenital heart disease (CHD) in the United States is estimated to be 6 per 1000 live-born full term infants. Recent advances in pediatric cardiology, surgery and critical care have significantly improved the survival rates of patients with CHD leading to an increase in prevalence in both children and adults. Children with CHD significant enough to require cardiac surgery frequently also undergo non-cardiac surgical procedures. Analysis of the Pediatric Health Information System database between 2004 and 2012 demonstrated that 41% of children who had undergone surgery to correct CHD in the first year of life also underwent at least one non-cardiac surgery by age 5. With this increased demand for non-cardiac procedures, anesthesiologists, pediatricians and other healthcare providers will encounter patients with repaired or unrepaired CHD and other cardiac diseases in their practice.

However, the information provided by national databases lack granularity and the information from single institutional data is limited.

This project aims to address this knowledge gap in quantifying the risk for cardiac patients coming for noncardiac procedures and identify the health care resource utilization and system to best care for this patient population. To conduct this study, we will create a multi-institutional collaboration between large and small centers to create a unique dataset spanning all the different variables that need to be considered in risk prediction for these patients including patient variables, hospital setting, and providers. The aggregate multiinstitutional data set may be used for benchmarking for national quality improvement efforts.

Keywords

Congenital Heart Disease in Children, Perioperative risk prediction, Adverse Postoperative Outcomes, Heart Diseases, Congenital Heart Defects

Eligibility

You can join if…

Open to people ages up to 21 years

  1. Males or females ages birth to 21 years.
  2. Patients diagnosed with congenital heart disease
  3. Patients undergoing a noncardiac procedure (surgical or nonsurgical)

You CAN'T join if...

  1. Patients with congenial heart disease undergoing a cardiac surgical procedure including pacemakers.
  2. Patients with congenital heart disease undergoing a catheterization(diagnostic or interventional) or an electrophysiology study

Locations

  • University of California, Los Angeles accepting new patients
    Los Angeles California 90095 United States
  • Texas Children's Hospital accepting new patients
    Houston Texas 77030 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Boston Children's Hospital
ID
NCT04604418
Study Type
Observational [Patient Registry]
Participants
Expecting 10000 study participants
Last Updated