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临床试验/NCT05679635
NCT05679635已完成不适用

Evaluation of Tracheal Pressure During Continuous Positive Airway Pressure Ventilation - a Prospective, Clinical Trial

Medical University Innsbruck2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年11月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
inspiratory tracheal pressure

研究概览

简要总结

This trial evaluates tracheal pressure values in intubated intensive care unit patients during continuous positive airway pressure without any ventilatory support, automatic tube compensation and assisted spontaneous breathing.

详细描述

Aim of this trial is to investigate if there are any significant differences between airway and tracheal pressure values during continuous positive airway pressure (CPAP) ventilation. For this purpose, a tracheal pressure measurement catheter is inserted into the tracheal tube and the obtained values are compared with the corresponding airway pressure measured on the ventilator. To further evaluate the impact of mild respiratory support automatic tube compensation and assisted spontaneous breathing with 4 cmH2O will be applied and measured pressure values compared as well.

We hypothesize that tracheal pressure will be significantly lower than airway pressure values during inspiration, which represents the primary outcome measure. Secondary outcome parameters include comparison of expiratory and mean pressure values of airway and tracheal pressure. Additionally, effects of mild respiratory support will be evaluated as well.

Measurement of inspiratory tracheal pressure might allow to calculate the pressure drop between the airway pressure at the Y-piece of the ventilator and the pressure at the trachea. Currently it is not known, if this pressure drop is significant during CPAP, which represents the rationale to perform this pilot study. In a second step it would be possible to determine if the recorded pressure drop can be used as a surrogate parameter for the respiratory drive in terms of a risk assessment for the development of patient self-inflected lung injury.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
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

  • Male and female subjects ≥ 18 years
  • Intubated patient during CPAP without pressure support
  • Informed consent

排除标准

  • Female subjects known to be pregnant
  • Known participation in another clinical trial
  • Critical pulmonary state (paO2/FiO2 ratio <100)

结局指标

主要结局

inspiratory tracheal pressure

时间窗: 10 minutes after insertion of the tracheal pressure measurement catheter

The lowest tracheal pressure value, representing the highest inspiratory effort, will be recorded from the ventilator

次要结局

  • mean tracheal pressure(10 minutes after insertion of the tracheal pressure measurement catheter)
  • peak tracheal pressure(10 minutes after insertion of the tracheal pressure measurement catheter)
  • inspiratory tracheal pressure during automatic tube compensation (ATC)(10 minutes after adding ATC)
  • inspiratory tracheal pressure during assisted spontaneous breathing (ASB)(10 minutes after adding ASB)

研究者

发起方
Medical University Innsbruck
申办方类型
Other
责任方
Sponsor

研究点 (2)

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