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临床试验/CTRI/2024/03/064172
CTRI/2024/03/064172已完成不适用

International observational study on airway management in operating room and non-operating room anaesthesia. STARGATE Study.

All India Institute of Medical Sciences Sijua Patrapada Bhubaneswar, Odisha India1 个研究点 分布在 1 个国家目标入组 10,500 人开始时间: 2024年3月25日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10,500
试验地点
1
主要终点
At least one of the following major peri-intubation adverse events like severe hypoxia, cardiovascular collapse, cardiac arrest.

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 (1). Despite important technological advances, airway management remains a major challenge in anaesthesiology.

The National Audit Project 4, published in 2011, for the first time addressed the need to systematically collect information on major airway-related complications in both the anaesthesia and critical care settings. While in the critical care setting the report provided important insights for improvement, incidence of major adverse events such as death, brain damage and need for emergency surgical airway appeared underestimated in anaesthesia (2) so that for every case captured by NAP4 there may be another 720 potential airway events if we consider hypoxemia and cardiovascular collapse (3).

Traditionally, airway management in anaesthesia has been described as anatomically difficult as opposed to airway management in critical care defined as physiologically difficult.

Critically ill patients are prone to a higher airway-related risk due to their underlying hypoxemia, shock, acidosis which expose them to the high incidence of adverse events, especially cardiovascular collapse, recently reported in the INTUBE study cohort (4). Data from large prospective 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 (5)(6).

These events are more common in case of difficulties with airway management so that first pass intubation failure significantly increases the risks (7)(8). 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 (9).

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • patients undergoing intubation 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

At least one of the following major peri-intubation adverse events like severe hypoxia, cardiovascular collapse, cardiac arrest.

时间窗: within 30 minutes from intubation or up to surgical incision

次要结局

  • To assess the current practice of airway management during anaesthesia worldwide.(with in 30 minutes from intubation or up to surgical incision.)

研究者

发起方
All India Institute of Medical Sciences Sijua Patrapada Bhubaneswar, Odisha India
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Neha Singh

All India Institute of Medical Sciences, Bhubaneswar

研究点 (1)

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