No intervention. It is observational
OtherNo intervention. It is observational
NCT Number: NCT04604418
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.
Interested in participating?
Request InfoUp to 21 year
All sexes
Observational
Hospital for Sick Kids, Toronto, Ontario, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
No intervention. It is observational
Time frame: during the procedure and up to 30-days following the procedure
Death
Time frame: following the procedure and up to 72 hours
The postoperative location of the patient is in the intensive care unit unexpectedly
Time frame: following the procedure and up to 72 hours
Patient required a ventilator or noninvasive positive pressure ventilation
Time frame: During the perioperative period
Time frame: 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
Time frame: during the procedure and up to 72 hours
Patient required cardiopulmonary ressuscitation
Time frame: Following the procedure and up to 72 hours
Defined as stroke or seizure by the provider
Time frame: Following the procedure and up to 72 hours
Defined based on creatinine and glomerular filtration
Contact information is provided by the study sponsor or research team.
Rachel Bernier
CONTACT
Viviane Nasr, MD
CONTACT
Boston Children's Hospital
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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