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Ultrasound Guided Cricoid and Paralaryngeal Pressure

2020年3月18日 更新者:Dr Lim Siu Min、University of Malaya

Impact of Ultrasound Guidance on the Performance of Accurate Cricoid and Paralaryngeal Pressure

The primary objective is to study impact of upper airway ultrasonography in guiding anaesthetic assistant into providing accurate cricoid pressure, or both cricoid and paralaryngeal pressure in those with oesophagus deviation, achieving sonographic proven oesophageal occlusion compared to those without ultrasound guidance.

研究概览

详细说明

All patients consented for the study were having their airway examined via US. Cross sectional sonography of the airway was performed to determine the anatomic relationship of the oesophagus relative to the trachea:

  1. before induction of anaesthesia
  2. after GA before external airway pressure manoeuvre
  3. after GA with external airway pressure manoeuvre.

US guided CP was applied on subjects with central oesophagus; CP and PLP were applied on subject with eccentric oesophagus anatomy.

PLP was performed by lateral compression on the eccentric oesophagus by fingertips under US guidance. To standardised the application of CP and PLP, only 2 well trained investigators were allowed to performed the CP and PLP, US scan on airway and patient recruitment. The conduct of trial involved 2 investigators where first investigator provide US scan, and second investigator provide compression of CP or PLP using fingertips guided by the instruction of first investigator.

研究类型

介入性

注册 (实际的)

51

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。

学习地点

      • Kuala Lumpur、马来西亚、59100
        • University Malaya Medical Centre

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

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

Elective list Under general anaesthesia Not intubated prior to OT

Exclusion Criteria:

Below 18 years old Pregnant Neck deformities Previous maxillofacial surgery

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:治疗
  • 分配:非随机化
  • 介入模型:单组作业
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Centrally located oesophagus post GA
Oesophagus remained central after general anaesthesia, cricoid pressure applied by fingertips under ultrasound guidance
cricoid pressure by fingertips applied under ultrasound guidance
实验性的:Eccentric located oesophagus post GA
Oesophagus eccentric located after general anaesthesia, paralaryngeal pressure and cricoid pressure applied by fingertips under ultrasound guidance
cricoid pressure with paralaryngeal pressure by fingertips applied under ultrasound guidance

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
The number of patients with eccentric oesophagus under general anesthesia, successfully occluded by using cricoid and paralaryngeal pressure.
大体时间:ultrasound assessment of oesophagus done after general anaesthesia, during application of cricoid pressure, and during application of cricoid and paralaryngeal pressure
we are studying the effectiveness of cricoid pressure versus cricoid and paralaryngeal pressure(novel technique) in those patients with eccentric oesophagus under general anaesthesia. We use ultrasound to determined the position of the oesophagus after patient under general anaethesia ( to group them under central oesophagus and eccentric oesophagus) and also to determine the success of oesophagus occlusion.
ultrasound assessment of oesophagus done after general anaesthesia, during application of cricoid pressure, and during application of cricoid and paralaryngeal pressure

次要结果测量

结果测量
措施说明
大体时间
The number of patients with central oesophagus under general anesthesia, successfully occluded by using cricoid pressure.
大体时间:ultrasound assessment of oesophagus done after general anaesthesia and during application of cricoid pressure
The objective is to study the effectiveness of cricoid pressure in those patients with central oesophagus under general anaesthesia. We use ultrasound to determined the position of the oesophagus after patient under general anaethesia, and also to determine the success of oesophagus occlusion.
ultrasound assessment of oesophagus done after general anaesthesia and during application of cricoid pressure

其他结果措施

结果测量
措施说明
大体时间
incidence of variation of oesophagus position before and after general anaesthesia
大体时间:ultrasound assessment of position of oesophagus before and after general anaesthesia
We use ultrasound to determine the position of osephagus (central or eccentric) to determine the incidence of variation of oesophagus position before and after general anaesthesia.
ultrasound assessment of position of oesophagus before and after general anaesthesia

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:Siu Min Lim, M. Anaes、University of Malaya

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

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)

2019年2月1日

初级完成 (实际的)

2019年5月30日

研究完成 (实际的)

2019年7月31日

研究注册日期

首次提交

2019年11月9日

首先提交符合 QC 标准的

2020年3月18日

首次发布 (实际的)

2020年3月23日

研究记录更新

最后更新发布 (实际的)

2020年3月23日

上次提交的符合 QC 标准的更新

2020年3月18日

最后验证

2020年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2018118-6867
  • 45835 (其他标识符:National Medical Research Register)

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.

cricoid pressure的临床试验

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