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临床试验/NCT03941002
NCT03941002Unknown不适用

Continuous Evaluation of Diaphragm Function During Assisted Mechanical Ventilation in Critically Ill Patients

University of Milan2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2019年9月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
25
试验地点
2
主要终点
Diaprhagm excursion

研究概览

简要总结

Aim of mechanical ventilation is to improve gas exchange and to unload the respiratory muscles delivering a form of mechanical support to the ventilation. At the same time, it is essential that the support is individually-tailored to avoid the development of muscular atrophy, a process called "ventilatory-induced diaphragm dysfunction"

Aim of the present study is that the continuous ultrasonographic assesment of diaphragm function, as obtained by the device under investigation (DiaMon, Respinor AS, Oslo, Norway) is related to the degree of effort of inspiratory muscles, as measured by gold-standard indices such as esophageal and gastric pressure measurement.

A secondary aim is that the data assessed by the device are related to a standard ultrasonographic examination performed by expert operators.

In particular, we will enroll a population of critically ill patients undergoing mechanical ventilation in assisted mode, and we will perform a decremental pressure support trial, with the following aims:

  1. to evaluate the performance of a continuous and automated device for the monitoring of diaphragm contractile activity, as compared to standard mechanical indices of respiratory effort such as the pressure-time product (PTP)
  2. to evaluate the performance of a continuous and automated device for the monitoring of diaphragm contractile activity, as compared to the ultrasonographic assesment of muscle function performed by an expert operator.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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

  • Acute respiratory failure which necessitated endotracheal intubation and mechanical ventilation, with ventilation in pressure-support mode.
  • Positive end-expiratory pressure (PEEP) lower than 10 cmH2O
  • Pressure support level between 4 and 10 cmH2O
  • Ratio between PaO2 and FiO2 >200 mmHg
  • Resolution of the cause of respiratory failure

排除标准

  • Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
  • Pregnancy
  • Circulatory failure

结局指标

主要结局

Diaprhagm excursion

时间窗: Study 1 day

Excursion (in mm) between expiration and inspiration

次要结局

  • Esophageal pressure swing(Study 1 day)
  • Pressure-time product(Study 1 day)

研究者

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

Davide Chiumello

Director of Intensive Care

University of Milan

研究点 (2)

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