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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Congenital Heart Disease in Children

Intervention / Treatment
-----------------
* Other: No intervention. It is observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females ages birth to 21 years. Patients diagnosed with congenital heart disease Patients undergoing a noncardiac procedure (surgical or nonsurgical) Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Maximum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention. It is observational|No intervention. It is observational|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Death | during the procedure and up to 30-days following the procedure | 
| Intensive Care Unit admission | The postoperative location of the patient is in the intensive care unit unexpectedly | following the procedure and up to 72 hours | 
| Postoperative mechanical support | Patient required a ventilator or noninvasive positive pressure ventilation | following the procedure and up to 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission Cardiac arrest: during the procedure and up to 72 hours Neurologic injury (stroke, seizure) following the procedure and up to 72 hours Renal injury following the procedure and up to 72 hours | Patient was discharged after the procedure and needed to be readmitted to the hospital is defined as readmission | following the procedure and up to 72 hours | 
| Cardiac arrest | Patient required cardiopulmonary ressuscitation | during the procedure and up to 72 hours | 
| Neurologic injury | Defined as stroke or seizure by the provider | Following the procedure and up to 72 hours | 
| Renal Injury | Defined based on creatinine and glomerular filtration | Following the procedure and up to 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Perioperative risk prediction, Adverse Postoperative Outcomes