预先和无呼吸高流量氧合在急诊科快速序贯插管中的应用（Pre-AeRATE）：一项多中心随机对照试验的研究方案。
Pre- and Apnoeic high flow oxygenation for RApid sequence intubation in The Emergency department (Pre-AeRATE): study protocol for a multicentre, randomised controlled trial.
机构信息
Emergency Medicine Department, National University Hospital, National University Health System, Level 4, 9 Lower Kent Ridge Road, Singapore, 119085, Singapore.
Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.
出版信息
Trials. 2019 Apr 4;20(1):195. doi: 10.1186/s13063-019-3305-8.
BACKGROUND
Maintaining adequate oxygenation during rapid sequence intubation (RSI) is imperative to prevent peri-intubation adverse events that can lead to increased duration of hospital and intensive care unit stay, or a prolonged vegetative state requiring long-term institutionalisation. Despite employing current best practices during RSI, desaturation during intubation still occurs. High-flow nasal cannula (HFNC) oxygenation may potentially improve oxygenation during pre- and apnoeic oxygenation to allow a longer safe apnoeic time for RSI.
OBJECTIVE
We aim to test the hypothesis that the use of humidified high-flow oxygenation via nasal cannula at 60 L/min maintains higher oxygen saturation compared with current usual care of non-rebreather mask and standard nasal cannula at an oxygen flow rate of 15 L/min for pre- and apnoeic oxygenation.
METHODS
This is a multi-centre randomised controlled trial enrolling adult patients aged 21 years and older who require rapid sequence intubation due to medical, surgical, or traumatic conditions in the Emergency Departments (EDs) of the National University Hospital and the Ng Teng Fong General Hospital. Eligible patients will undergo randomisation at an equal ratio into intervention or control arms. The primary endpoint will be the lowest oxygen saturation achieved during the first intubation attempt from time of administration of paralytic agent until quantitative end-tidal carbon dioxide is detected if the first intubation attempt is successful, or until the start of the second attempt if it is not.
DISCUSSION
Prolongation of safe apnoea time through maintenance of oxygen saturation above 90% using HFNC oxygenation during RSI could potentially change current clinical practice, improve standard of care, and translate to better outcomes for patients.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT03396094 . Registered on 10 January 2018.
背景
在快速序贯插管（RSI）过程中保持充足的氧合至关重要，以防止插管期间发生不良事件，这些事件可能导致住院和重症监护病房停留时间延长，或导致长时间的植物状态，需要长期住院治疗。尽管在 RSI 期间采用了当前的最佳实践，但在插管过程中仍会发生脱氧。高流量鼻导管（HFNC）氧合可能会在预给氧和无通气期间潜在地改善氧合，从而为 RSI 提供更长的安全无通气时间。
目的
我们旨在检验以下假设，即与当前的非重复呼吸面罩和标准 15L/min 鼻导管预给氧和无通气时的常规氧疗相比，使用 60L/min 湿化高流量氧气通过鼻导管进行氧合可维持更高的氧饱和度。
方法
这是一项多中心随机对照试验，纳入了因内科、外科或创伤原因需要 RSI 的 21 岁及以上成年患者，这些患者在国立大学医院和黄廷芳综合医院的急诊科。符合条件的患者将以相等的比例随机分为干预组或对照组。主要终点是从给予肌松剂到成功进行第一次插管尝试时检测到定量呼气末二氧化碳（如果第一次插管尝试成功）或在不成功时开始第二次尝试时的第一次插管尝试期间达到的最低氧饱和度。
讨论
通过 HFNC 氧合在 RSI 期间维持氧饱和度在 90%以上，从而延长安全无通气时间，这可能会改变当前的临床实践，改善护理标准，并为患者带来更好的结果。
试验注册
ClinicalTrials.gov，NCT03396094。于 2018 年 1 月 10 日注册。
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