Efficacy of High Flow Nasal Cannula Oxygen to Reduce Desaturation During Tracheal Intubation (HAPI)
2014年8月11日 更新者:Prof Jean-Damien RICARD、Hôpital Louis Mourier
High Flow Nasal Cannula Oxygen for Pre and During Procedure Oxygenation During Tracheal Intubation: Comparison With High FiO2 Non Rebreathing Bag Reservoir Facemasks
Tracheal intubation of critically ill patients is associated in the intensive care unit (ICU) with significant complications and morbidity.
Patient desaturation is one of the most common complications that may lead to cardiac arrest despite pre-intubation oxygenation.
Preoxygenation can be improved by the use of non-invasive ventilation, but this technique can be cumbersome to implement in the context of urgent intubation and more importantly it does not insure oxygenation during intubation.
High flow nasal cannula oxygen therapy is a technique that has been shown to improve patient oxygenation in the context of acute hypoxemic respiratory failure.
It bears the potential to be of clinical benefit in the setting of tracheal intubation in the ICU to ensure patient safety.
The purpose of this study is to compare pre- and per-intubation (during intubation) oxygenation with either a conventional high FiO2 oxygen bag reservoir facemask (current standard practice) or high flow nasal cannula oxygen therapy (new practice to be implemented in our ICU).
研究概览
详细说明
Pre-oxygenation is ensured in our ICU with a high FiO2 nonrebreathing facemask, except in patients already under high flow nasal cannula oxygen therapy because of acute hypoxemic respiratory failure.
A nasal catheter is positioned to ensure a low oxygen flow during laryngoscopy.
Whether or not all patients should benefit from high flow nasal cannula oxygen therapy for pre-oxygenation remains unknown.
In order to improve quality of care delivered to our patients and in anticipation of a change in our practice, we decided to record prospectively oxygen parameters during and immediately of intubation using a facemask and to compare them with parameters obtained in patients intubated after our change in practice.
The change of practice consists in the systematic use of high flow nasal cannula oxygen therapy to ensure pre and during procedure (tracheal intubation)oxygenation.
研究类型
观察性的
注册 (实际的)
101
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Colombes、法国、92701
- Medico-surgical ICU
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
ICU patients requiring tracheal intubation
描述
Inclusion Criteria:
- ICU patient requiring tracheal intubation
Exclusion Criteria:
- age < 18 years
- cardiac arrest
- acute respiratory failure requiring immediate high flow nasal cannula oxygen, defined as patient with SpO2 < 95% while under 15 L:min oxygen with a nonrebreathing facemask
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
|---|
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conventional high FiO2 bag reservoir facemask
this group of patients is intubated according to our current practice that requires the use of a high FiO2 nonrebreathing with bag reservoir facemask to ensure preoxygenation in patients requiring tracheal intubation.
a small nasal catheter is inserted just before laryngoscopy to ensure a low oxygen flow to allow oxygenation during laryngoscopy.
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high flow nasal cannula oxygen
we wish to change our standard practice of preoxygenation and expand our use of high flow nasal cannula oxygen therapy to the tracheal intubation setting.
Currently, used of high flow oxygen nasal cannula oxygen therapy to ensure oxygenation during intubation is limited to the patients already under high flow nasal cannula oxygen.
the change of practice consists in the systematic use of high flow nasal cannula oxygen therapy in all patients requiring tracheal intubation in the ICU.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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lowest pulse oxymetry (SpO2) during intubation
大体时间:from beginning of laryngoscopy to completed intubation
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from beginning of laryngoscopy to completed intubation
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mean pulse oxymetry during intubation
大体时间:from beginning of laryngoscopy to completed intubation
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from beginning of laryngoscopy to completed intubation
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pulse oxymetry after preoxygenation
大体时间:3min prexoxygenation
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3min prexoxygenation
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pulse oxymetry after intubation
大体时间:at connection of the patient to the ventilator
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at connection of the patient to the ventilator
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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mean pulse oxymetry
大体时间:one, five and thirty minutes after intubation
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one, five and thirty minutes after intubation
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number of pulse oxymetry below 90%
大体时间:from laryngoscopy to 30 minutes once tracheal intubation completed
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from laryngoscopy to 30 minutes once tracheal intubation completed
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number of pulse oxymetry below 80%
大体时间:from laryngoscopy to 30 minutes once tracheal intubation completed
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from laryngoscopy to 30 minutes once tracheal intubation completed
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其他结果措施
结果测量 |
大体时间 |
|---|---|
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cardiac arrest
大体时间:during and immediately after procedure
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during and immediately after procedure
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hemodynamic instability defined as arterial systolic blood pressure below 80 mmHg
大体时间:during and immediately after procedure
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during and immediately after procedure
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Jean-Damien Ricard, MD, PhD、Hopital Louis Mourier, AP-HP, Colombes, France
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Sztrymf B, Messika J, Bertrand F, Hurel D, Leon R, Dreyfuss D, Ricard JD. Beneficial effects of humidified high flow nasal oxygen in critical care patients: a prospective pilot study. Intensive Care Med. 2011 Nov;37(11):1780-6. doi: 10.1007/s00134-011-2354-6. Epub 2011 Sep 27.
- Sztrymf B, Messika J, Mayot T, Lenglet H, Dreyfuss D, Ricard JD. Impact of high-flow nasal cannula oxygen therapy on intensive care unit patients with acute respiratory failure: a prospective observational study. J Crit Care. 2012 Jun;27(3):324.e9-13. doi: 10.1016/j.jcrc.2011.07.075. Epub 2011 Sep 29.
- Lenglet H, Sztrymf B, Leroy C, Brun P, Dreyfuss D, Ricard JD. Humidified high flow nasal oxygen during respiratory failure in the emergency department: feasibility and efficacy. Respir Care. 2012 Nov;57(11):1873-8. doi: 10.4187/respcare.01575. Epub 2012 Mar 13.
- Ricard JD. High flow nasal oxygen in acute respiratory failure. Minerva Anestesiol. 2012 Jul;78(7):836-41. Epub 2012 Apr 24.
- Miguel-Montanes R, Hajage D, Messika J, Bertrand F, Gaudry S, Rafat C, Labbe V, Dufour N, Jean-Baptiste S, Bedet A, Dreyfuss D, Ricard JD. Use of high-flow nasal cannula oxygen therapy to prevent desaturation during tracheal intubation of intensive care patients with mild-to-moderate hypoxemia. Crit Care Med. 2015 Mar;43(3):574-83. doi: 10.1097/CCM.0000000000000743.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年3月1日
初级完成 (实际的)
2012年11月1日
研究完成 (实际的)
2013年1月1日
研究注册日期
首次提交
2012年10月1日
首先提交符合 QC 标准的
2012年10月3日
首次发布 (估计)
2012年10月4日
研究记录更新
最后更新发布 (估计)
2014年8月12日
上次提交的符合 QC 标准的更新
2014年8月11日
最后验证
2014年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.