Outcomes and Health Care Resource Utilization in Pediatric Congenital Heart Disease Patients Undergoing Non-Cardiac Procedures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 10
- 主要终点
- Postoperative mechanical support
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 21 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females ages birth to 21 years.
- •Patients diagnosed with congenital heart disease
- •Patients undergoing a noncardiac procedure (surgical or nonsurgical)
排除标准
- •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
结局指标
主要结局
Postoperative mechanical support
时间窗: following the procedure and up to 72 hours
Patient required a ventilator or noninvasive positive pressure ventilation
Mortality
时间窗: during the procedure and up to 30-days following the procedure
Death
Intensive Care Unit admission
时间窗: following the procedure and up to 72 hours
The postoperative location of the patient is in the intensive care unit unexpectedly
Intraoperative cardiac event
时间窗: During the perioperative period
次要结局
- 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)
研究者
Viviane Nasr
Associate Professor
Boston Children's Hospital
