跳至主要内容
临床试验/NCT07265882
NCT07265882招募中不适用

Bed Side Assessment in Patients With Acute Respiratory Failure Under Invasive Mechanical Ventilation

Fondazione IRCCS Policlinico San Matteo di Pavia1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年11月14日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Statistical prevalence of respiratory system instability , defined as indexed lung hysteresis at PEEP lower than 10 cmH2O.

研究概览

简要总结

The goal of this study is to learn about the respiratory mechanics in patients undergoing mechanical ventilation. The investigators can achieve this through the offline analysis of data provided by the ventilator. Within the field of respiratory mechanics, the study focuses particularly on the quantification of lung instability.

What does lung instability mean? By this definition, the investigators refer to the part of lung tissue that opens during inspiration and then collapses during the subsequent expiration. The more diseased the lung (for example, in the case of viral pneumonia), the greater the quantity of this tissue.

How is lung instability measured? In the context of the study analysis, lung instability is measured through the analysis of the low flow pressure-volume loop during ventilation. This graph illustrates how the volume of air in the lungs varies in response to the pressures applied by the ventilator during slow inflation and deflation phases. This maneuver is considered quick and safe and has been an integral part of our clinical practice for several years. Through this maneuver, investigators can examine the range of pressures provided by the ventilator during tidal ventilation. To assess lung instability, hysteresis is analyzed, which represents a distinctive characteristic of the pressure-volume loop. Greater hysteresis indicates a higher degree of lung instability.

During the study, investigators will record not only hysteresis but also classical respiratory mechanics parameters (for example, elastance of the respiratory system, i.e., how stiff the lung is), parameters regarding gas exchange (blood oxygen and carbon dioxide levels), biometric data (for example, height and weight), and imaging (CT scans, lung ultrasound, and electrical impedance tomography) to relate them to the degree of lung instability.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients undergoing passive mechanical ventilation

排除标准

  • hemodynamic instability
  • confirmed intracranial hypertension

结局指标

主要结局

Statistical prevalence of respiratory system instability , defined as indexed lung hysteresis at PEEP lower than 10 cmH2O.

时间窗: up to 45 months

Lung instability is defined as indexed hysteresis \> 100. Where: * Hysteresis (ml) is calculated as the area enclosed between inspiratory and expiratory limb of the low flow pressure volume loop. * indexed hysteresis corresponds to the hysteresis area normalized for the applied driving pressure (plateau pressure minus PEEP)

次要结局

  • Description of classical respiratory mechanics related to lung instability(up to 45 months)

研究者

发起方
Fondazione IRCCS Policlinico San Matteo di Pavia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marco Pozzi

Principal Investigator

Fondazione IRCCS Policlinico San Matteo di Pavia

研究点 (1)

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