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Clinical Trials/NCT04604418
NCT04604418
Recruiting
Not Applicable

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

Boston Children's Hospital10 sites in 2 countries10,000 target enrollmentOctober 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital Heart Disease in Children
Sponsor
Boston Children's Hospital
Enrollment
10000
Locations
10
Primary Endpoint
Postoperative mechanical support
Status
Recruiting
Last Updated
last year

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2020
End Date
December 31, 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Viviane Nasr

Associate Professor

Boston Children's Hospital

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

Outcomes

Primary Outcomes

Postoperative mechanical support

Time Frame: following the procedure and up to 72 hours

Patient required a ventilator or noninvasive positive pressure ventilation

Mortality

Time Frame: during the procedure and up to 30-days following the procedure

Death

Intensive Care Unit admission

Time Frame: following the procedure and up to 72 hours

The postoperative location of the patient is in the intensive care unit unexpectedly

Intraoperative cardiac event

Time Frame: During the perioperative period

Secondary Outcomes

  • Cardiac arrest(during the procedure and up to 72 hours)
  • Neurologic injury(Following the procedure and up to 72 hours)
  • Renal Injury(Following the procedure and up to 72 hours)
  • 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(following the procedure and up to 72 hours)

Study Sites (10)

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