Ignite Creation Date:
2024-05-06 @ 3:22 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04604418
Status:
RECRUITING
Last Update Posted:
2023-11-21
First Post:
2020-10-16
Brief Title:
Outcomes and Health Care Resource Utilization in Pediatric Congenital Heart Disease Patients Undergoing Non-Cardiac Procedures
Sponsor:
Boston Childrens Hospital
Organization:
Boston Childrens Hospital
Study Overview
Official Title:
Outcomes and Health Care Resource Utilization in Pediatric Congenital Heart Disease Patients Undergoing Non-Cardiac Procedures
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None