Errors and AEs in the setting of neonatal surgery performed in the NICU

NICU 中进行的新生儿手术的错误和不良事件

• 批准号: 8523946
• 负责人: KuoJen Tsao
• 金额: $ 18.63万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-10 至 2016-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8523946
• 关键词: Adverse event; Anesthetic Gases; Back; Cessation of life; Childhood; Classification; Complex; Critical Illness; Data; Dimensions; Effectiveness of Interventions; Equipment; Event; Exposure to; Future; Hospitalized Child; Hospitals; Incidence; Infant; Institute of Medicine (U.S.); Intervention; Knowledge; Lighting; Measures; Medical Errors; Methodology; Methods; Neonatal; Neonatal Intensive Care; Neonatal Intensive Care Units; Operating Rooms; Operative Surgical Procedures; Patients; Population; Process; Reporting; Research Personnel; Risk; Safety; Selection Bias; Site; Standardization; System; Time; United States; Validity and Reliability; Ventilator; evidence base; experience; hazard; high risk; improved; medical specialties; mortality; natural hypothermia; neonate; operation; patient safety; prevent; routine practice; tool

DESCRIPTION (provided by applicant): With the improvements in neonatal intensive care and recognition of the hazards in transporting high- risk neonates to the operating rooms, surgical intervention in the neonatal intensive care unit (NICU) has become routine practice. While some complications have been thought to be similar, patient safety, associated with high-risk operations in the NICU, has never been rigorously studied. This may be the result of the lack of definition and standardization of error and adverse events as it relates to neonatal surgery. Surgery and neonatal intensive care units are major contributors to medical errors and adverse events. The error rate among surgical patients have been demonstrated to be two to four times of those estimated in the Institute of Medicine report, with approximately 30% contributing to surgical deaths. Nearly half of adverse events are related to surgery. Due to this disproportionate number of events related to surgery, several interventions have been proposed to increase patient safety including improving the quality or teamwork in the operating rooms. However, the type and incidence of errors and adverse events due to off-site surgery, such as in the NICU, is unknown. The purpose of this project is to determine type and incidence of errors and adverse events associated with neonatal surgery performed in the NICU. The primary hypothesis of this project is that errors and adverse events in the setting of neonatal surgery performed in the NICU are underestimated and inaccurately identified with current reporting systems. Specific Aim 1: To prospectively determine the type and incidence of errors and adverse events in neonatal surgery performed in the NICU. Specific Aim 2: To develop an errors and adverse events reporting tool for neonatal surgery in the NICU. Specific Aim 3: To validate the NICU surgery-specific errors and adverse events reporting tool in a pilot observational trial.

描述（由申请人提供）：随着新生儿重症监护的改善和对将高危新生儿运送到手术室的危害的认识，新生儿重症监护室（NICU）中的手术干预已成为常规做法。虽然一些并发症被认为是相似的，但与NICU中高风险手术相关的患者安全性从未得到严格研究。这可能是由于缺乏与新生儿手术相关的错误和不良事件的定义和标准化。手术和新生儿重症监护病房是医疗差错和不良事件的主要原因。手术患者的错误率已被证明是医学研究所报告中估计的错误率的两到四倍，其中约30%导致手术死亡。近一半的不良事件与手术有关。由于与手术相关的事件数量不成比例，已提出了几种干预措施来提高患者安全性，包括提高手术室的质量或团队合作。然而，由于非现场手术（如在NICU）导致的错误和不良事件的类型和发生率尚不清楚。本项目的目的是确定在新生儿重症监护室进行的新生儿手术相关的错误和不良事件的类型和发生率。本项目的主要假设是，在NICU中进行的新生儿手术中的错误和不良事件被低估，并且当前的报告系统识别不准确。具体目标1：前瞻性确定在NICU进行的新生儿手术中错误和不良事件的类型和发生率。具体目标2：为NICU的新生儿手术开发错误和不良事件报告工具。具体目标3：在一项初步观察性试验中验证NICU手术特定错误和不良事件报告工具。