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临床试验/NCT05519969
NCT05519969已完成不适用

A Multicentre Audit of the Incidence of Pulmonary Aspiration With Different Fasting Regimens - European Preoperative Fasting Audit (EUROFAST)

Uppsala University1 个研究点 分布在 1 个国家目标入组 307,162 人开始时间: 2023年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
307,162
试验地点
1
主要终点
Pulmonary aspiration

研究概览

简要总结

The new European Society of Anaesthesiology and Intensive Care (ESAIC) preoperative fasting guideline recommends a one hour minimum fasting time for clear fluids. This represents a major change in the practice of pediatric anaesthesia.

During the transition to shorter fasting times on a global scale, we need a large multicenter audit to monitor the incidence of pulmonary aspiration.

详细描述

The purpose of preoperative fasting is to achieve an empty stomach at the time of anaesthesia induction.

Most current fasting guidelines all take into account the balance between the risk of pulmonary aspiration and the harmful effects of prolonged preoperative fasting. However, there is increased awareness among pediatric as well as general anaesthesiologists that many patients suffer from prolonged duration of fasting in spite of the reasonable nominal respective limits of 6-4-2 hours. Prolonged fasting may be harmful, especially in small children, but also in adults with a poor nutritional status.

The new European Society of Anaesthesiology and Intensive Care (ESAIC, 2022) preoperative fasting guideline recommends a one-hour minimum fasting time for clear fluids. This represents a major change in the practice of paediatric anaesthesia. During the transition to shorter fasting times on a global scale, we need a large multicentre audit to monitor the incidence of pulmonary aspiration.

The primary aim of the European Preoperative Fasting Audit (EUROFAST) is to determine the safety of reducing the required fasting time for clear fluids to at least one hour in children fasting before elective procedures requiring general anaesthesia (as recommended in the ESAIC guideline).

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
0 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children, age < 16 years old
  • General anesthesia
  • Exclusion criteria
  • Age > 15 years
  • Procedure without general anesthesia
  • General anesthesia performed at center with less than 1000 pediatric cases per year

排除标准

  • 未提供

结局指标

主要结局

Pulmonary aspiration

时间窗: Intraoperative

The incidence of confirmed pulmonary aspiration according to the study protocol

次要结局

  • Suspected pulmonary aspiration(Intraoperative)

研究者

发起方
Uppsala University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Frykholm

Assoc. Prof.

Uppsala University

研究点 (1)

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