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

Condition(s) studied

Investigational drug(s) / intervention(s)

No intervention. It is observational: No intervention. It is observational

Study 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

Primary outcome measure(s)

• Mortality — during the procedure and up to 30-days following the procedure
  Death
• Intensive Care Unit admission — following the procedure and up to 72 hours
  The postoperative location of the patient is in the intensive care unit unexpectedly
• Postoperative mechanical support — following the procedure and up to 72 hours
  Patient required a ventilator or noninvasive positive pressure ventilation
• Intraoperative cardiac event — During the perioperative period

Trial sites (10)

More Boston Children's Hospital trials in Canada

Other trials for the same condition