Apneic Oxygenation Including Precipitous Intubations During RSI in the ED
追踪信息 | |||
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首次提交日期 ICMJE | September 11, 2018 | ||
首次发布日期e ICMJE | October 3, 2018 | ||
最后更新发布日期 | October 3, 2018 | ||
预计研究开始日期 ICMJE | October 2018 | ||
预计主要完成日期 | October 31, 2018 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
Lowest oxygen saturation overall[ Time Frame: Time between neuromuscular blockade and 2 minutes after completion of endotracheal intubation ] Lowest oxygen saturation between overall control and intervention groups |
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原始主要观察测量 ICMJE | 与当前相同 | ||
目前的二级观察 ICMJE |
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描述性信息 | |||
简略标题 ICMJE | Apneic Oxygenation Including Precipitous Intubations During RSI in the ED | ||
正式标题 ICMJE | Randomized Controlled Trial of Apneic Oxygenation Including Precipitous Intubations During RSI in the Emergency Department | ||
简要概况 | This RCT is testing the efficacy of apneic oxygenation during endotracheal intubation in the emergency department. Currently the standard practice in the ED when performing endotracheal intubation is that some providers use apneic oxygenation (the application of a nasal cannula at 15LPM) throughout the intubation procedure, while others do not apply apneic oxygenation. Initial literature in the operating room showed that apneic oxygenation helps prevent desaturation during the procedure. However, the latest literature conducted in critical care settings (one study in the ICU and one in the ED) questions the efficacy of this intervention in critically ill patients; however, no harm has been shown. Our study aims to test this intervention further by adding in a special subset of patients that was excluded from prior studies, precipitous intubations, or those patients that have to be intubated quickly and cannot have adequate pre-oxygenation. We hypothesize that apneic oxygenation will be more efficacious in this subset than in the overall ED population. We will randomize patients requiring endotracheal intubation into intervention (apneic oxygenation) and control (no apneic oxygenation). We will measure the lowest arterial oxygen saturation from the start of the intubation procedure through 2 minutes after intubation is complete. |
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详细说明 | |||
研究类型 ICMJE | Interventional | ||
研究阶段 | N/A | ||
研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Prevention |
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适用条件 ICMJE | |||
干预项目 ICMJE |
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研究工具 |
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招募信息 | |||
招募状态 ICMJE | Not yet recruiting | ||
预计入组 ICMJE |
346 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | October 2019 | ||
预计主要完成日期 | October 31, 2018 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: - The inclusion criteria for our study will include patients 18 years or older who require emergent endotracheal intubation utilizing rapid sequence intubation (RSI) in the Emergency Department with first attempt taken by a resident or attending physician working in the emergency department. This includes Emergency Medicine attending physicians and residents as well as non-Emergency Medicine rotators (e.g.., Internal Medicine residents who are rotating through the Emergency Department). Exclusion Criteria: - Exclusion criteria include patients who are in cardiac arrest, or if the patient received any positive pressure ventilation (i.e, BPAP, CPAP, BVM) in the emergency department before RSI. | ||
性别 |
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年龄 | 最小年龄:18 Years ,最大年龄:N/A | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | United States | ||
管理信息 | 数据检测委员会 | No | |
研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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IPD 共享声明 |
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责任方 | Ilya Ostrovsky, MD,Rutgers, The State University of New Jersey | ||
研究赞助商 ICMJE | Rutgers, The State University of New Jersey | ||
合作者 ICMJE | |||
研究员 ICMJE |
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PRS 账户 | Rutgers, The State University of New Jersey | ||
验证日期 | October 2018 | ||
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |