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临床试验/NCT04507958
NCT04507958已完成不适用

The Accuracy of Electronic Stethoscope for Confirmation of Endotracheal Intubation Position in Full Personal Protective Equipment

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年9月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
The ability to detect selective lung isolation states

研究概览

简要总结

To investigate the feasibility of auscultation to confirm the endotracheal tube position by using electronic stethoscope for clinicians who wear the full personal protective equipment.

详细描述

After the pandemic outbreak of Coronavirus disease 2019 (COVID-19) in many countries, the number of critical ill patients are rapidly growing. Critical ill COVID-19 patients inevitably require endotracheal intubation for ventilator support. The chest X-rays, ultrasound, and stethoscope are three tools that can detect whether or not bronchial intubation has occurred. Auscultation by using the stethoscope is the routine first-line tool for this purpose. However, clinician who wears the full personal protective equipment (PPE) is very difficult to perform adequate auscultation with conventional stethoscope. In addition, the X-ray machines and ultrasound are very difficult to enter the negative-pressure isolation room and may raise the risks of infection spread. By using the electronic stethoscope amplified by the Bluetooth speaker, the clinician with full PPE may still hear the proper lung sound. In addition, electronic stethoscope has a good portability that can be easily brought into the isolation room. For patients undergoing surgery with general anesthesia, endotracheal tube is often mandatory and auscultation with stethoscope is routinely applied. Therefore, the investigators can simulate the circumstance that clinician with a full PPE to use the electronic stethoscope for confirmation of the proper endotracheal tube position. In addition, patients undergoing thoracic surgery require the single-lung ventilation which could be a proper simulation scenario for detection of bronchial intubation by using electronic stethoscope for clinicians with PPE.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing thoracic surgery in general anesthesia with endotracheal tube insertion and bronchial blocker.

排除标准

  • Previous lung surgical history
  • Patients with organs dysfunction, such as impaired liver function, eg. Aspartate Aminotransferase or Alanine Aminotransferase >100; liver cirrhosis > Child B class; impaired renal function, calculated glomerulus filtration rate< 60 ml/min/1.73 m2; cardiac dysfunction, such as heart failure > New York Heart Association class II, coronary arterial disease

结局指标

主要结局

The ability to detect selective lung isolation states

时间窗: 90 seconds

Perform the auscultation by investigator A with traditional stethoscope, then by investigator B with electronic stethoscope under full PPE, to detect bronchial or tracheal intubation. The accuracy of successful detection (%) is the primary outcome.

次要结局

  • User experience of the electronic stethoscope(Through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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