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临床试验/NCT04797520
NCT04797520尚未招募不适用

Assessing Diagnostic Accuracy of Core Stethoscope Auscultation vs. Point of Care Ultrasound in Localizing Correct Placement of Endotracheal Tube

Stanford University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年11月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
2
主要终点
Localization of endotracheal tube placement by the presence/absence of breath sounds detected by Core-Eko augmented stethoscope

研究概览

简要总结

Misplacement of endotracheal tube (ETT) can have devastating complications for patients, some of which include respiratory failure, atelectasis, and pneumothorax.

There are a number of ways to verify the correct placement of ETT, with the stethoscope auscultation being commonly used despite its low accuracy (60-65%) in distinguishing tracheal from bronchial intubation (4-6). The gold standard techniques include Chest X Ray or fiberoptic bronchoscope (7-8), with a recent study showing point-of-care ultrasound. However, these techniques are expensive, time-consuming, often not readily available and require substantial training before users can reliably utilize them. Given intubation is often performed in urgent clinical settings, a technique that can reliably yet efficiently localize ETT would be beneficial.

Tele-auscultation system via Core stethoscope (Eko, Berkeley, CA) has been shown to be effective in identifying pathologic heart murmur (10) yet its potential use in guiding the correct placement of ETT has not been explored. We set out to study the suitability of Core stethoscope in detecting the correct placement of ETT.

研究设计

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

入排标准

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

入选标准

  • Any patients under the age of 18
  • Surgery requiring an ETT
  • Consent/parental consent to

排除标准

  • Possible difficult airway
  • Significant lung pathology
  • with any major cardiac anomaly

结局指标

主要结局

Localization of endotracheal tube placement by the presence/absence of breath sounds detected by Core-Eko augmented stethoscope

时间窗: During assessment with Core-Eko augmented stethoscope auscultation (5min)

Presence of breath sounds will be assessed and recorded using Core-Eko augmented stethoscope, in conjunction with the smartphone interface over Bluetooth, by auscultating patient's chest. The technology will display breath sounds as a visual soundwave on the smartphone. As a result, this will be used to determine location of endotracheal tube (for example, if breath sounds absent in the left lung, we would infer that the tube is in the right bronchus).

Localization of endotracheal tube placement by the presence/absence of lung pleural linings movement by ultrasound

时间窗: During assessment with point of care ultrasound (10min)

Ultrasound placed vertically on the anterior chest of a patient will assess for the presence/absence of the horizontal movement of the two lung pleural linings with respiration.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chi-Ho Ban Tsui

Professor of Anesthesiology, Perioperative and Pain Medicine, Stanford University

Stanford University

研究点 (2)

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