神经重症监护病房患者的拔管策略及其与预后的关联：ENIO多中心国际观察性研究
Extubation strategies in neuro-intensive care unit patients and associations with outcomes: the ENIO multicentre international observational study.
作者信息
Cinotti Raphaël, Pelosi Paolo, Schultz Marcus J, Aikaterini Ioakeimidou, Alvarez Pablo, Badenes Rafael, Mc Credie Victoria, Elbuzidi Abdurrahmaan Suei, Elhadi Muhammed, Godoy Daniel Agustin, Gurjar Mohan, Haenggi Matthias, Kaye Callum, Mijangos-Méndez Julio Cesar, Piagnerelli Michael, Piracchio Romain, Reza Syed Tariq, Stevens Robert D, Yoshitoyo Ueno, Asehnoune Karim
机构信息
Department of Anaesthesia and Critical Care, Hôpital Guillaume et René Laennec, University Hospital of Nantes, Saint-Herblain, France.
Departement of Surgical Sciences and Integrated Diagnostics, University of Genoa, Genoa, Italy.
出版信息
Ann Transl Med. 2020 Apr;8(7):503. doi: 10.21037/atm.2020.03.160.
BACKGROUND
Prolonged invasive ventilation is common in patients with severe brain injury. Information on optimal management of extubation and on the use of tracheostomy in these patients is scarce. International guidelines regarding the ventilator liberation and tracheostomy are currently lacking.
METHODS
The aim of 'Extubation strategies in Neuro-Intensive care unit patients and associations with Outcomes' (ENIO) study is to describe current management of weaning from invasive ventilation, focusing on decisions on timing of tracheal extubation and tracheostomy in intensive care unit (ICU) patients with brain injury. We conducted a prospective, international, multi-centre observational study enrolling patients with various types of brain injury, including trauma, stroke, and subarachnoid haemorrhage, with an initial Glasgow Coma Score equal or less than 12, and a duration of invasive ventilation longer than 24 hours from ICU admission. ENIO is expected to include at least 1,500 patients worldwide. The primary endpoint of the ENIO study is extubation success in the 48 hours following endotracheal tube removal. The primary objective is to validate a score predictive of extubation success. To accomplish this, the study population will be randomly divided to a development cohort (2/3 of the included patients) and a validation cohort (the remaining 1/3). Secondary objectives are: to determine the incidence of extubation success rate according to various time-frames (within 96 hours, >96 hours after extubation); to validate (existing) prediction scores for successful extubation according to various time-frames and definitions (i.e., tracheostomy as extubation failure); and to describe the current practices of extubation and tracheostomy, and their associations.
DISCUSSION
ENIO will be the largest prospective observational study of ventilator liberation and tracheostomy practices in patients with severe brain injury undergoing invasive mechanical ventilation, providing a validated predictive score of successful extubation.
TRIAL REGISTRATION
The ENIO study is registered in the Clinical Trials database: NCT03400904.
背景
在重度脑损伤患者中，长时间有创通气很常见。关于这些患者拔管的最佳管理以及气管造口术的使用的信息很少。目前缺乏关于呼吸机撤离和气管造口术的国际指南。
方法
“神经重症监护病房患者的拔管策略及其与结局的关联”（ENIO）研究的目的是描述目前有创通气撤机的管理情况，重点关注脑损伤重症监护病房（ICU）患者气管拔管和气管造口术的时机决策。我们进行了一项前瞻性、国际性、多中心观察性研究，纳入各种类型脑损伤的患者，包括创伤、中风和蛛网膜下腔出血，初始格拉斯哥昏迷评分等于或低于12分，且自入住ICU起有创通气时间超过24小时。预计ENIO在全球范围内将纳入至少1500名患者。ENIO研究的主要终点是气管插管拔除后48小时内拔管成功。主要目标是验证一个预测拔管成功的评分。为实现这一目标，研究人群将被随机分为一个开发队列（纳入患者的2/3）和一个验证队列（其余1/3）。次要目标包括：根据不同时间框架（拔管后96小时内、>96小时）确定拔管成功率的发生率；根据不同时间框架和定义（即将气管造口术视为拔管失败）验证（现有）成功拔管的预测评分；描述目前的拔管和气管造口术实践及其关联。
讨论
ENIO将是对接受有创机械通气的重度脑损伤患者的呼吸机撤离和气管造口术实践进行的最大规模前瞻性观察性研究，提供一个经过验证的成功拔管预测评分。
试验注册
ENIO研究已在临床试验数据库中注册：NCT03400904。
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