跳至主要内容
临床试验/NCT02052869
NCT02052869撤回不适用

Spirometric Detection of Esophageal Intubation

University Medical Center Groningen2 个研究点 分布在 1 个国家开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
sensitivity/specificity of the fully-automatic device

研究概览

简要总结

In endotracheal intubation, it is essential that the trachea is intubated and not the esophagus. In suboptimal situations (outside an operating theatre), malpositioning of the endotracheal tube occurs frequently and is often fatal. The diagnostic tools that are available in the operating theatre are not appropriate for out-of-hospital situations because of several reasons. Moreover, these methods mostly take some time to provide the desired information and don't have optimal specificity and sensitivity. In order to allow fast diagnosis of this potentially fatal complication, we have developed a fully-automatic detection device to diagnose endotracheal tube malpositioning within 2 seconds.

A high sensitivity/specificity of the algorithm for waveform-analysis was demonstrated in healthy patients and patients with pulmonary diseases (decreased pulmonary compliance).

A new stand-alone device with integrated sensors and microprocessor was developed that gives immediate diagnosis, and stores data for subsequent research purpose. This device will be evaluated in perioperative situations to demonstrate the high sensitivity and specificity in patients in a clinical setting.

详细描述

The fundamental algorithm for waveform analysis is unchanged, but an additional detection algorithm is incorporated for improved detection of ventilation efforts. In addition, sensors are integrated, automatic feedback electronics are improved, and the device is made more user friendly to be appropriate for out-of-hospital situations in demanding environments.

In addition, waveforms will be recorded for later analysis and evaluation of the diagnostic value of a thoracic push ( a gentle push on the sternum) to detect tube position.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • General anesthesia with endotracheal intubation required for the procedure
  • Age: 18 years and older
  • Total intravenous anesthesia with propofol (in order ro guarantee adequate hypnosis during the procedure)

排除标准

  • Oesophageal pathology
  • Patients at risk for desaturation (SpO2 < 95%) if 20 seconds of apnoea is induced after adequate preoxygenation

结局指标

主要结局

sensitivity/specificity of the fully-automatic device

时间窗: first 3 minutes after intubation

Determine the sensitivity/specificity of the fully-automatic device to diagnose oesophageal intubation based on test ventilations

次要结局

  • Evaluate the value of the supplementary algorithm(first 3 minutes of intubation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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