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临床试验/NCT04377633
NCT04377633已完成不适用

Impact of an Anesthesia-handover Checklist on Perioperative Outcomes of Elderly Patients Undergoing Major Noncardiac Surgery: A Prospective Before-and-after Study

Peking University First Hospital1 个研究点 分布在 1 个国家目标入组 1,421 人开始时间: 2020年7月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,421
试验地点
1
主要终点
A composite incidence of all complications within 30 days after surgery.

研究概览

简要总结

With the increasing number of surgical cases, intraoperative handover of anesthesia care is common and inevitable. Verbal handover from one anesthesiologist to another during surgery are being used in many hospitals. However, verbal handover is often an informal, unstructured process during which omissions and errors can occur. It is possible that an improved anesthesia handover may reduce the related adverse events. This study aims to test the hypothesis that use of a well-designed, structured handover-checklist to improve handover quality may decrease the occurrence of postoperative complications in elderly patients undergoing major noncardiac surgery.

详细描述

It was estimated that more than 9 million patients undergo surgery with a complete anesthesia handover each year worldwide. Verbal handover from one anesthesiologist to another during surgery are being used in many hospitals; and there is no unified patient handover guideline at present.

It is well recognized that the transfer-of-care is a point of vulnerability where valuable patient information can be distorted and omitted. A previous study of the investigators showed that handover of anesthesia care was associated with a higher risk of delirium in elderly patients after major noncardiac surgery. The World Health Organization has included communication during patient care handovers among its top 5 patient safety initiatives.

It is possible that an improved anesthesia-handover protocol may reduce the related adverse events. Many efforts have performed to optimize handover processes. However, handover quality between anesthesiologists has rarely been investigated. The investigators hypothesize that a well-designed, structured handover-checklist will improve handover quality and reduce the occurrence of postoperative complications.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Prevention
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elderly patients (aged 65 years and over);
  • Scheduled to undergo major non-cardiac surgery with an expected duration of at least 2 hours;
  • Requirement of complete handover between anesthesiologists during surgery (initial anesthesiologist no longer returns).

排除标准

  • Preoperative history of schizophrenia, epilepsy, Parkinsonism or myasthenia gravis;
  • Inability to communicate before surgery (coma, profound dementia or language barrier);
  • Craniocerebral injury or neurosurgery;
  • Severe liver dysfunction (Child-Pugh grade C), severe renal dysfunction (requiring dialysis), or expected survival of <24 hours.

结局指标

主要结局

A composite incidence of all complications within 30 days after surgery.

时间窗: Up to 30 days after surgery.

Include organ injury (delirium, acute kidney injury, and myocardial injury) within 3 days and other major complications (class II or higher on Clavien-Dindo classification) within 30 days after surgery.

次要结局

  • Length of stay in the intensive care unit after surgery.(Up to 30 days after surgery.)
  • Incidence of major complications within 30 days after surgery.(Up to 30 days after surgery.)
  • All-cause mortality within 30 days after surgery.(Up to 30 days after surgery.)
  • Intensive care unit admission after surgery.(Up to 30 days after surgery.)
  • Length of hospital stay after surgery.(Up to 30 days after surgery.)
  • Incidence of organ injury (delirium, acute kidney injury, and acute myocardial injury) within 3 days after surgery.(Up to 3 days after surgery.)

研究者

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

Dong-Xin Wang

Professor, Department of Anaesthesiology and Critical Care Medicine

Peking University First Hospital

研究点 (1)

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