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临床试验/NCT06425354
NCT06425354招募中不适用

Use of 'Mechanical Power' as a Predictor of Increased Serum and Pulmonary Proinflammatory Cytokine Concentrations in Patients With Acute Hypoxemic Respiratory Failure: A Prospective Observational Study

University of Roma La Sapienza1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
1
主要终点
Patients who exceed 17 J/min of MP

研究概览

简要总结

The aim of this study is to report the proportion of patients with acute hypoxemic respiratory failyre (AHRF) undergoing mechanical ventilation who exceed 17 J/min of mechanical power (MP) and the difference in terms of proinflammatory cytokine concentration in blood samples and bronchoalveolar lavage.

The main questions it aims to answer are:

  1. Which is the proportion of patients who exceed 17 J/min of mechanical power (MP) during the first 72 hours of mechanical ventilation?
  2. Is there a difference in terms of cytokine concentration in patients undergoing mechanical power >17 J/min compared to <17 J/min?

Patients will be divided into two groups based on respiratory mechanics measurements: low MP group (average MP <17 J/min) and high MP group (average MP ≥17 J/min). The researchers will collect blood and BAL samples and perform cytokine assays.

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 with AHRF (P/F <300 mmHg) undergoing invasive mechanical ventilation within 7 days from the onset of symptoms
  • Invasive mechanical ventilation for less than 6 hours
  • Evidence of newly developed lung consolidation on chest imaging (X-ray, CT)
  • Age ≥18 years

排除标准

  • Prior invasive mechanical ventilation during the same hospitalization
  • Tracheostomy
  • Severe anemia (Hb<7g/dL)
  • Severe neutropenia
  • Renal insufficiency or RRT (Renal Replacement Therapy)
  • Noradrenaline >0.5 mcg/kg/min
  • Pregnancy
  • Extracorporeal circulation (ECCO2R, ECMO)
  • Life expectancy <24 hours as clinically judged
  • Lack of consent

结局指标

主要结局

Patients who exceed 17 J/min of MP

时间窗: 4 years

Proportion of patients with AHRF undergoing mechanical ventilation who exceed 17 J/min of MP

次要结局

  • Inflammatory cytokines(4 years)

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Francesco Alessandri

Prof

University of Roma La Sapienza

研究点 (1)

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