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At a Glance
Age
Up to 21
Sex
Any
Study type
Observational
Participants needed
10,000 (estimated)
Sponsor
Boston Children's Hospital · Other
Who this trial is looking for
This trial is looking for children and young adults with congenital heart disease who are undergoing non-cardiac procedures. Participants will help researchers understand the risks and healthcare needs for these patients.
Are You a Good Fit for This Trial?
You may be able to join if
I am between birth and 21 years old.
I have been diagnosed with congenital heart disease.
I am undergoing a non-cardiac procedure.
You may not be able to join if
I have congenital heart disease and am undergoing a cardiac procedure.
I have congenital heart disease and am undergoing a catheterization or electrophysiology study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 card…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Males or females ages birth to 21 years.
2. Patients diagnosed with congenital heart disease
3. Patients undergoing a noncardiac procedure (surgical or nonsurgical)
Exclusion Criteria:
1. Patients with congenial heart disease undergoing a cardiac surgical procedure includin…
Inclusion Criteria:
1. Males or females ages birth to 21 years.
2. Patients diagnosed with congenital heart disease
3. Patients undergoing a noncardiac procedure (surgical or nonsurgical)
Exclusion Criteria:
1. Patients with congenial heart disease undergoing a cardiac surgical procedure including pacemakers.
2. Patients with congenital heart disease undergoing a catheterization(diagnostic or interventional) or an electrophysiology study
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