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Comparison of Tracheal Ultrasound With Capnography for Intubation Confirmation During CPR Wearing PPE

2021年5月30日 更新者:Samsung Medical Center

Comparison of Tracheal Ultrasound With Capnography for Intubation Confirmation During CPR (Cardiopulmonary Resuscitation) Wearing PPE (Personnel Protective Equipment): A Prospective Comparative Study

It is very important to ensure the tube placement in patients with cardiac arrest and unrecognized misplacement of endo-tracheal tube can lead to morbidity and mortality. In recent pandemic situations such as COVID-19 (Coronavirus disease-19), the number of cases of cardiopulmonary resuscitation with personal protective equipment (PPE) have increased. In those cases, existing methods such as auscultation and chest uprising have to be limited. Quantitative waveform capnography is recommended as the gold standard for confirming correct endotracheal tube placement in the 2010 American HeartAssociation (AHA) Guidelines for Cardiopulmonary resuscitation (CPR) and Emergency Cardiovascular Care (ECC), but it has some well-known limitations in cardiac arrest patients.

Ultrasonography is a non-invasive, real-time diagnostic tool commonly used during resuscitation. Especially, tracheal ultrasonography can be performed in real-time when the tube is passed through the trachea or esophagus. Previous prospective studies revealed that tracheal ultrasonography could feasibly and rapidly confirm tracheal intubation during emergency intubation.

There have already been several studies comparing the accuracy of tracheal ultrasound and capnography, but there was no study comparing the two tools under the constraints of PPE that is essential in pandemic situations as in this study. This study aimed to determine the accuracy of tracheal ultrasonography in assessing endotracheal tube position during CPR with PPE.

研究概览

地位

未知

条件

详细说明

When patients in cardiopulmonary arrest enter a emergency room (ER) or patients staying in a ER have a cardiopulmonary arrest, participants perform intubation and CPR. When it is judged as a high-risk group with a high probability of droplet infection, all participants in resuscitation team should wear personal protective equipment. Tracheal ultrasound and end-tidal carbon dioxide are used to confirm the placement of tube. The gold standard is the direct visualization using laryngoscope. The time it takes to confirm the placement of tube is also measured.

研究类型

介入性

注册 (预期的)

34

阶段

  • 不适用

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

研究联系人备份

学习地点

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 至 100年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 1. cardiopulmonary arrest patients receiving emergency intubation and CPR
  • 2. patients judged to need to wear PPE according to the judgement of the clinician

Exclusion Criteria:

  • 1. sign for "do not resuscitate (DNR)"
  • 2. patients unable to perform tracheal ultrasound due to trauma of the site
  • 3. patients unable to perform tracheal ultrasound due to oropharynx cancer
  • 4. patients unable to perform tracheal ultrasound due to placement of tracheal cannula
  • 5. patients not used tracheal ultrasound for checking tube placement

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

  • 主要用途:诊断
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他:Tracheal ultrasound
The patients in cardiopulmonary arrest should be performed tracheal ultrasound when tube is passed through the trachea or esophagus.
When checking tracheal ultrasound, several signs are used in judgements. Direct signs include reverberation artifact and double ring sign. Indirect sign means checking the bilateral lung sliding.

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
Accuracy
大体时间:during intubation procedure
The gold standard is direct visualization using laryngoscopy. Tracheal ultrasound is performed regardless of whether it is in real-time or not.
during intubation procedure

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

  • 学习椅:Hee Yoon, Professor、Samsung medical center, Emergency department

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。

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1月30日

初级完成 (预期的)

2022年2月1日

研究完成 (预期的)

2022年7月1日

研究注册日期

首次提交

2020年12月21日

首先提交符合 QC 标准的

2020年12月27日

首次发布 (实际的)

2020年12月30日

研究记录更新

最后更新发布 (实际的)

2021年6月2日

上次提交的符合 QC 标准的更新

2021年5月30日

最后验证

2020年12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

  • 2020-11-115

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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.

tracheal ultrasound的临床试验

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