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临床试验/NCT02737917
NCT02737917已完成不适用

EmergeNcy Department Apneic Oxygenation Versus Usual Care During Rapid Sequence Intubation : A Randomized Controlled Trial (The ENDAO Trial)

New York City Health and Hospitals Corporation2 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2016年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
206
试验地点
2
主要终点
Mean (Average) Arterial Oxygen Saturation

研究概览

简要总结

To determine the impact, if any the application of oxygen during the apnea period of rapid sequence intubation has on patients being intubated in the emergency department.

详细描述

Hypoxia may occur during rapid sequence intubation (RSI) of emergency department patients (1-4). This condition may increase the risk of the patient suffering a cardiac arrest secondary to securing the airway. A part of RSI is pre-oxygenation, which is defined as placing the patient on 100% fraction of inspired O2 for 3 minutes prior to administering the induction agents (i.e. sedative and neuromuscular blocker) in order to increase the amount of oxygen present in the functional residual capacity of the patients lungs to prolong oxygen saturating during the apneic period of endotracheal intubation (5-9). In the last decade, physicians have developed a process known as diffuse apneic oxygenation (DAO) in order to mitigate the risk of oxygen desaturation during this apneic period. The process entails leaving the patient on high flow nasal cannula (HFNC) oxygen during the act of visualizing the vocal cords and placing the endotracheal tube. Over the years the practice has started to become more common in emergency departments, operating rooms and ICU's all over the world. Recently, a randomized controlled trial (called The FELLOW Trial) of this practice demonstrated no difference in desaturation rates between those patients that received DAO and those that did not (usual practice) in patients in the ICU (10). Some have commented that the findings of this study cannot be applied to emergency department patients, and so evidence is lacking in regards to this population.

Purpose of the study:

Although studies have started to investigate the efficacy of DAO in preventing desaturation during RSI, evidence is still lacking in the emergency department patient population. The primary question being asked is: does diffuse apneic oxygenation increase the average lowest arterial oxygen saturation during rapid sequence intubation when compared to usual care? Secondary question being asked is: does diffuse apneic oxygenation decrease the incidence of desaturation in general, as well as hypoxemia and severe hypoxemia? The third question being asked is: does diffuse apneic oxygenation increase the time to desaturation?

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

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

  • Any patient greater than 18 years of age that presents to the Lincoln medical and Mental Health Center Emergency Department requiring endotracheal intubation.

排除标准

  • Patients will be excluded from the primary outcome analysis, but included in the intention to treat analysis for the secondary outcome if they are not pre-oxygenated to the standard RSI protocol of 3 minutes with 100% fraction of inspired oxygen (FiO2) by means of bag valve mask, HFNC and/or non-rebreather; patients will be excluded from the study in general if they are in cardiac or traumatic arrest or they are intubated without an apneic period (awake intubation)

研究组 & 干预措施

Diffuse apneic oxygenation

Experimental

This group of patients will receive the standard of care treatment of rapid sequence intubation (pre-oxygenation, induction and intubation) plus the application of oxygen.

干预措施: Oxygen (Other)

Diffuse apneic oxygenation

Experimental

This group of patients will receive the standard of care treatment of rapid sequence intubation (pre-oxygenation, induction and intubation) plus the application of oxygen.

干预措施: Standard of care (Other)

Usual care

Other

This group of patients will receive the standard of care treatment of rapid sequence intubation (pre-oxygenation, induction and intubation)

干预措施: Standard of care (Other)

结局指标

主要结局

Mean (Average) Arterial Oxygen Saturation

时间窗: within 2 minutes of confirmation of endotracheal tube placement

the average oxygen saturation as measured by peripheral capillary oxygen saturation (SpO2)

次要结局

  • Rates of Desaturation(within 2 minutes of confirmation of endotracheal tube placement)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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