RecruitingNCT04604418

Outcomes and Health Care Resource Utilization in Pediatric Congenital Heart Disease Patients Undergoing Non-Cardiac Procedures


Sponsor

Boston Children's Hospital

Enrollment

10,000 participants

Start Date

Oct 1, 2020

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Max Age: 21 Years

Inclusion Criteria3

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

Exclusion Criteria2

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

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Interventions

OTHERNo intervention. It is observational

No intervention. It is observational


Locations(10)

University of California, Los Angeles

Los Angeles, California, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Children's Healthcare of Atlanta - Egleston Hospita

Atlanta, Georgia, United States

Boston Children's Hospital

Boston, Massachusetts, United States

University of Minnesota Medical Center

Minneapolis, Minnesota, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Texas Children's Hospital

Houston, Texas, United States

Children's Hospital of the King's Daughter

Norfolk, Virginia, United States

Hospital for Sick Kids

Toronto, Ontario, Canada

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NCT04604418


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