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临床试验/NCT05759299
NCT05759299招募中不适用

International obServational sTudy on AiRway manaGement in operAting Room and Non-operaTing Room anaEsthesia

University of Turin, Italy10 个研究点 分布在 5 个国家目标入组 10,500 人开始时间: 2024年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
10,500
试验地点
10
主要终点
Major peri-intubation adverse event

研究概览

简要总结

According to WHO, more than 230 million major surgical procedures are carried out under general anaesthesia each year worldwide. Despite important technological advances, airway management remains a major challenge in anaesthesiology. Data from large perspective studies on current incidence of major peri-intubation adverse events are lacking in the anaesthesia setting, especially on outcomes such as peri-intubation cardiovascular collapse, severe hypoxemia, and cardiac arrest. These events are more common in case of difficulties with airway management so that first pass intubation failure significantly increase the risks. Moreover, it has been documented that even transient hypotension during general anaesthesia, may have long-term consequences and may be associated with a worse outcome in patients undergoing non-cardiac surgery. The primary aim of the study is to assess the current incidence of major adverse events during advanced airway management for anaesthesia in patients undergoing elective or emergency surgery and in the setting of nonoperating room anesthesia. The secondary aim is to assess the current practice of airway management during anesthesia worldwide.

STARGATE Study will be a large international observational study recruiting all consecutive adult (≥ 18 years old) patients undergoing general anesthesia in operating room and outside operating room. Primary outcome will be a composite of cardiovascular collapse, cardiac arrest and severe hypoxemia.

详细描述

According to WHO, more than 230 million major surgical procedures are carried out under general anaesthesia each year worldwide. Despite important technological advances, airway management remains a major challenge in anesthesiology. Data from large perspective studies on current incidence of major peri-intubation adverse events are lacking in the anesthesia setting, especially on outcomes such as peri-intubation cardiovascular collapse, severe hypoxemia, and cardiac arrest. These events are more common in case of difficulties with airway management so that first pass intubation failure significantly increase the risks. Moreover, it has been documented that even transient hypotension during general anesthesia, may have long-term consequences and may be associated with a worse outcome in patients undergoing non-cardiac surgery. The primary aim of the study is to assess the current incidence of major adverse events during advanced airway management for anesthesia in patients undergoing elective or emergency surgery and in the setting of non-operating room anesthesia. The secondary aim is to assess the current practice of airway management during anesthesia worldwide.

Study design: International, multicenter, prospective cohort study

Inclusion criteria: We will include all adult (≥ 18 years old) patients undergoing advanced airway management for general anaesthesia in operating room (OR) or non-operating room anaesthesia (NORA).

Exclusion criteria: Airway management during cardiopulmonary resuscitation; critically ill patients undergoing intubation due to their underlying clinical condition.

Primary outcome: At least one of the following major peri-intubation adverse events occurring within 30 minutes from induction or up to surgical incision: severe hypoxia, cardiovascular collapse, cardiac arrest.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All adult (≥ 18 years old) patients undergoing advanced airway management for general anaesthesia in operating room (OR) or non-operating room anaesthesia (NORA).

排除标准

  • Airway management during cardiopulmonary resuscitation.
  • Critically ill patients undergoing intubation due to their underlying clinical condition

结局指标

主要结局

Major peri-intubation adverse event

时间窗: 30 minutes from induction

Defined as at least one of the following events: * Cardiovascular collapse (at least one of the following): 1. Systolic arterial pressure \< 65 mmHg 2. Systolic arterial pressure \< 90 mmHg for \> 15 minutes 3. New need of vasopressors and/or fluid load \> 15 ml/kg to maintain the target blood pressure * Cardiac arrest * Severe hypoxemia (SpO2 \< 80%)

次要结局

  • Difficult facemask ventilation(30 minutes from induction)
  • First pass success rate(30 minutes from induction)
  • Minor peri-intubation adverse events(30 minutes from induction)

研究者

发起方
University of Turin, Italy
申办方类型
Other
责任方
Sponsor

研究点 (10)

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