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临床试验/NCT05203536
NCT05203536已完成不适用

ICEBERG STUDY. Respiratory Mechanics Assessment During Assisted Mechanical Ventilation

University of Milano Bicocca8 个研究点 分布在 5 个国家目标入组 298 人开始时间: 2021年9月1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
298
试验地点
8
主要终点
Correlation between respiratory system mechanical properties and ICU mortality

研究概览

简要总结

To verify the association between respiratory system mechanical properties (ΔP, ΔPL,dyn, Pmus, Pplat and CRS and CL,dyn) assessed during assisted modes of ventilation (as average over the first three days since enrollment) and ICU mortality.

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

  • Acute Hypoxaemic Respiratory Failure (defined as respiratory failure requiring invasive mechanical ventilation with a PaO2/FiO2< 300 mmHg) during the course of ICU stay (including ARDS).
  • Invasive mechanical ventilation in one of these modes: Pressure A/C, PRVC, SIMV PC, PSV, NAVA, PAV+, BiPAP
  • Presence of spontaneous breathing activity (ventilator triggering), since 6 hours and no longer than 48 hours
  • Patient for full active management at this point.

排除标准

  • Age <18 years old
  • Pregnancy
  • Active air leaks
  • Moribund state
  • Patient has passed a spontaneous breathing trial (if performed for clinical indication)
  • Known COPD with history of home oxygen therapy and/or non invasive ventilation and/or GOLD III-IV. Non invasive ventilation for sleep apnea is NOT an exclusion criteria.

结局指标

主要结局

Correlation between respiratory system mechanical properties and ICU mortality

时间窗: 90 days

Difference between mean values of driving pressure in survivors and non-survivors at ICU discharge.

次要结局

  • Correlation between respiratory system compliance and ICU mortality(90 days)
  • Correlation between pressure muscle index and ICU mortality(90 days)
  • Correlation between plateau pressure and ICU mortality(90 days)
  • Correlation between muscle pressure and ICU mortality(90 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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