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临床试验/NCT04604418
NCT04604418招募中不适用

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

Boston Children's Hospital10 个研究点 分布在 2 个国家目标入组 10,000 人开始时间: 2020年10月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Viviane Nasr

Associate Professor

Boston Children's Hospital

研究点 (10)

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