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临床试验/NCT07112976
NCT07112976
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Effect of a Higher Positive End-expiratory Pressure (PEEP) on Lung Hyperinflation and Collapse in Patients With Severe Pneumonia: a Computed Tomography Study

Istituto Clinico Humanitas1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2022年10月1日最近更新:

概览

阶段
不适用
状态
已完成
发起方
Istituto Clinico Humanitas
入组人数
47
试验地点
1
主要终点
Lung response to a higher PEEP

概览

简要总结

At their institution, the investigators routinely assess the individual response of mechanically ventilated patients with acute respiratory failure to higher positive end-expiratory pressure (PEEP) by examining changes in lung aeration through lung computed tomography (CT). They typically obtain two lung CT scans during an end-expiratory hold, one at a PEEP of 10 cmH2O and another at 15 cmH2O. Recruitment and hyperinflation are measured by assessing the decrease in the volume of non-aerated lung regions (with a density greater than -100 HU) and the increase in the volume of hyperinflated lung regions (with a density of less than -900 HU) between the two CT scans. If recruitment exceeds hyperinflation, the response to higher PEEP is considered "positive", and medical doctors are encouraged to treat that patient with a higher PEEP. Conversely, if hyperinflation exceeds recruitment, the response is deemed "negative", and a higher PEEP is discouraged. This assessment is further complemented by a "PEEP test," during which gas exchange (specifically arterial oxygen and carbon dioxide tension) and respiratory system mechanics (including compliance) are evaluated while ventilating with PEEP levels of 10 and 15 cmH2O.

In this retrospective analysis, the investigators will focus on patients with severe pneumonia who underwent the two lung CTs as part of their routine clinical practice. They will retrieve data on primary demographic characteristics, significant comorbidities, causes of pneumonia, severity of acute illness, and treatments delivered. Additionally, they will review the results of the quantitative analysis of the lung CT scans taken at 10 and 15 cmH2O, and the PEEP tests. The primary aim of this study is to determine the proportion of patients with net hyperinflation in response to higher PEEP.

研究设计

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

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

  • adult (≥18 years of age) patients
  • admitted to ICU from 1/10/2022 to 31/12/2024
  • with severe pneumonia
  • treated with mechanical ventilation
  • who underwent the two lung CTs at 10 and 15 cmH2O
  • Exclusion Criteria
  • pneumothorax
  • pneumomediastinum
  • lung CT was obtained with contrast medium to rule out pulmonary embolism

排除标准

  • 未提供

结局指标

主要结局

Lung response to a higher PEEP

时间窗: The effects of a higher PEEP will be assessed by comparing the CT scans taken at ICU admission, with a PEEP of 10 or 15 cmH2O, within the same subject. Usually, the interval between the two CT scans is a few minutes.

The primary study objective is to evaluate the effects of higher PEEP with quantitative analysis of lung CT scans in patients with severe pneumonia. We hypothesize that 50% of these patients will exhibit more hyperinflation than recruitment. We measure recruitment and hyperinflation by assessing the change in the volume of non-aerated lung regions (with a density greater than -100 HU) and hyperinflated lung regions (with a density of less than -900 HU) between the two CT scans.

次要结局

未报告次要终点

研究者

发起方
Istituto Clinico Humanitas
申办方类型
Other
责任方
Sponsor

研究点 (1)

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