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临床试验/NCT04319939
NCT04319939已完成不适用

Diaphragm Ultrasound Measurements With Variations in Modes of Ventilation

University of Chicago1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2020年2月5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
66
试验地点
1
主要终点
End expiratory diaphragm thickness in controlled and spontaneous modes

研究概览

简要总结

The overall objective of the study is to conduct an observational study involving intensive care unit patients receiving mechanical ventilation and determine if there are differences in diaphragm thickness ultrasound measurements during expiratory and inspiratory phases in a controlled and spontaneous mode. For patients receiving sedatives, an additional set of measurements will be taken during a standard of care interruption of sedatives

详细描述

In this study diaphragm ultrasound measurements at end-expiration and peak inspiration phases in assist control and pressure support mode in consented patients admitted to the medical intensive care unit. One-time measurements will be obtained during the first 48hrs that the patients are receiving mechanical ventilation. In patients receiving sedatives, additional measurements will be taken after an interruption of sedatives. Measurements will be compared between modes and on assist-control before and after an interruption of sedatives.

Three consecutive images will be obtained by an investigator that is blinded to the mode (controlled vs. spontaneous). Once measurements are obtained, a second investigator will switch to the other mode (controlled vs. spontaneous) and the blinded investigator will obtain three consecutive images after the patient has adjusted to the subsequent mode (one minute). Tidal volumes will be matched between modes as close as possible. The order of modes to ultrasound (controlled then spontaneous or spontaneous then controlled) will be determined by the non-blinded second investigator. Once the ultrasound measurements are obtained by the research team, image acquisition is concluded for the enrolled patient. The ventilator will be programmed back to the original settings determined by the medical ICU team.

The hypothesis is that the end-expiration diaphragm ultrasound measurement will be thicker in spontaneous mode than controlled mode.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Patients > 18 years of age
  • intubated and mechanically ventilated for < 48 hours at the time of screening

排除标准

  • pregnancy
  • history of diaphragmatic paralysis
  • neuromuscular blockade
  • cardiac arrest

结局指标

主要结局

End expiratory diaphragm thickness in controlled and spontaneous modes

时间窗: Less than 48 hours after mechanical ventilation

Diaphragm ultrasound measurement at end expiration in assist control mode and pressure support mode

次要结局

  • Variance in peak inspiration thickness in controlled and spontaneous modes(Less than 48 hours after mechanical ventilation)
  • p0.1 measurements in controlled and spontaneous modes(Less than 48 hours after mechanical ventilation)
  • Thickening fraction in controlled and spontaneous modes(Less than 48 hours after mechanical ventilation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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