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| Name | Class |
|---|---|
| The Hospital for Sick Children | OTHER |
| Vanderbilt University Medical Center | OTHER |
| University of Minnesota | OTHER |
| Children's Hospital of Philadelphia |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention. It is observational | Other | No intervention. It is observational |
| 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 |
| Intraoperative cardiac event | During the perioperative period |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with congenital heart disease and presenting to the participating institution for a noncardiac procedure are included in the study.
All patients will be included.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Viviane Nasr, MD | Contact | 617-355-6225 | viviane.nasr@childrens.harvard.edu | |
| Rachel Bernier | Contact | 857-218-5348 | Rachel.Bernier@childrens.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Viviane Nasr, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Active, not recruiting | Los Angeles | California | 90095 | United States | |
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| OTHER |
| Children's Healthcare of Atlanta | OTHER |
| Baylor College of Medicine | OTHER |
| Children's National Research Institute | OTHER |
| Children's Hospital of The King's Daughters | OTHER |
| University of California, Los Angeles | OTHER |
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| 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 |
| Children's National Medical Center |
| Recruiting |
| Washington D.C. |
| District of Columbia |
| 20310 |
| United States |
|
| Children's Healthcare of Atlanta - Egleston Hospita | Active, not recruiting | Atlanta | Georgia | 30322 | United States |
| Boston Children's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
|
| University of Minnesota Medical Center | Active, not recruiting | Minneapolis | Minnesota | 55455 | United States |
| Children's Hospital of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37232 | United States |
|
| Texas Children's Hospital | Recruiting | Houston | Texas | 77030 | United States |
|
| Children's Hospital of the King's Daughter | Terminated | Norfolk | Virginia | 23507 | United States |
| Hospital for Sick Kids | Recruiting | Toronto | Ontario | M5G 1X8 | Canada |
|