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Preoxygenation With High-flow Nasal Oxygen in Adult Trauma Patients During Rapid Sequence Induction Anaesthesia (PRIOR-Trauma)

2022年3月22日 更新者:Malin Jonsson Fagerlund、Karolinska University Hospital

Preoxygenation With High-flow Nasal Oxygen in Comparison to Standard Face Mask in Adult Trauma Patients During Rapid Sequence Induction Anesthesia- a Prospective, Non-randomized, Before-and-after Study

Previous studies investigating apnoea oxygenation has shown that delivering oxygen via a high flow can maintain adequate oxygen saturation levels in a patient for over 30 minutes.

It has recently been demonstrated, in several studies, that High Flow Nasal Oxygen (HFNO) used during preoxygenation in patients undergoing emergency surgery is at least equally effective as preoxygenation with standard tight fitting mask. Data from these recent studies investigating arterial oxygen saturation levels during rapid sequence induction anaesthesia have not been able to detect any difference between the two methods. The mean apnea time among the patients in the previous studies have been relatively short.

Patients suffering traumatic injuries could be more prone to desaturate during prolonged apnea due to being hemodynamic unstable or suffering injuries to the respiratory tract.

Based on the above, the aim is now to conduct a trial where trauma patients are preoxygenated with high flow nasal oxygen before anaesthetised with rapid sequence induction (RSI) technique. The trial is set to be a before-and-after study. During approximately 6 to 9 months data will be registered from trauma patients undergoing emergency anaesthesia where preoxygenation is performed according to standard rutin, with traditional facemask. During the coming six to nine months trauma patients undergoing emergency anaesthesia will be preoxygenated with high flow nasal oxygen. Data will be registered and compared to the data collected from the patients preoxygenated with facemark.

The general purpose of this project is to compare the preoxygenation technique based on HFNO with traditional preoxygenation with a tight fitting mask, with the main focus being oxygen saturation levels, during rapid sequence induction (RSI) intubation in trauma patients in need of immediate anaesthesia.

研究概览

研究类型

观察性的

注册 (预期的)

300

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。

学习联系方式

学习地点

      • Stockholm、瑞典、SE-17176
        • 招聘中
        • Karolinska University Hospital Solna
        • 接触:

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

All eligable patients suffering Level 1 trauma and in need of emergency anaesthesia will be included.

描述

Inclusion Criteria:

  • 1 Adult, ≥18 years old
  • 2 Level 1 trauma with patients in need of emergency anaesthesia before leaving the trauma unit (trauma room or nearby operating theatre).

Exclusion Criteria:

  • 1 Patients with or with risk of skull or facial injuries where application of nasal cannula is decided to be avoided by the trauma team.

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
干预/治疗
Tight fitting facemask
Preoxygenation with tight facemask, 100% oxygen.
Preoxygenation with tight facemask, 10 L/min, 100% oxygen.
High flow nasal oxygen
Preoxygenation with high flow nasal oxygen, 100% oxygen
Preoxygenation with high flow nasal oxygen, 40-70 L/min, 100% oxygen.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Number of patients with a peripheral oxygen saturation (SpO2) below 93%
大体时间:From start of anaesthesia until 1 minute after tracheal intubation.
Compare the number of patients with a peripheral oxygen saturation (SpO2) below 93% from induction of anesthesia (when induction drug is administered) until one minute after intubation between the group preoxygenated using HFNO and the group preoxygenated with traditional tight-fitting mask.
From start of anaesthesia until 1 minute after tracheal intubation.

次要结果测量

结果测量
措施说明
大体时间
Lowest median SpO2.
大体时间:From start of anaesthesia until 1 minute after tracheal intubation.
Lowest median SpO2 during preoxygenation using HFNO compared to traditional preoxygenation from when first anesthetic drug is administered until 1 minute after intubation
From start of anaesthesia until 1 minute after tracheal intubation.
End tidal gas levels
大体时间:At the first breath after tracheal intubation.
Difference in levels of ETO2 and ETCO2 in the first breath after intubation with HFNO oxygenation compared to traditional pre-oxygenation.
At the first breath after tracheal intubation.
Time span from start of preoxygenation until intubation.
大体时间:Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
Compare the time span from start of preoxygenation until intubation between the HFNO group and the group with traditional preoxygenation.
Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
Time span from entering trauma room until intubation.
大体时间:Could vary depending on patient and trauma, from a couple of minutes up to an hour.
Time span from when the patient enters the trauma room until intubation in the HFNO group compared to the group with traditional preoxygenation.
Could vary depending on patient and trauma, from a couple of minutes up to an hour.
Difficulties with induction of anaesthesia
大体时间:Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
Compare the perceived difficulties during induction of anaesthesia between the HFNO technique and traditional preoxygenation, for example tolerance to mask or nasal cannula
Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
Frequency of complications
大体时间:Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.
Frequency of complications (aspiration, signs of intraabdominal/intracranial gas, difficulties intubating the trachea, hypotension) in the HFNO group compared to the group preoxygenated with traditional facemask.
Could vary depending on patient and trauma, from a couple of minutes up to 20-30 minutes.

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:Malin Jonsson Fagerlund、Karolinska University Hospital and Karolinska Institute

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 (实际的)

2021年6月1日

初级完成 (预期的)

2023年1月1日

研究完成 (预期的)

2023年1月1日

研究注册日期

首次提交

2021年6月7日

首先提交符合 QC 标准的

2021年6月10日

首次发布 (实际的)

2021年6月15日

研究记录更新

最后更新发布 (实际的)

2022年4月4日

上次提交的符合 QC 标准的更新

2022年3月22日

最后验证

2022年3月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • PRIOR-Trauma

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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