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临床试验/NCT05363332
NCT05363332招募中不适用

Impact and Sequelae of High Ventilatory Drive in Critically Ill COVID-19 Patients With Acute Respiratory Failure Requiring High Flow Oxygen or Mechanical Ventilation: Mechanistic and Genomic Characterization Using Artificial Intelligence

Corporacion Parc Tauli3 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2021年11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
126
试验地点
3
主要终点
Respiratory drive

研究概览

简要总结

Critically ill COVID-19 patients with acute respiratory failure, in the intensive care unit (ICU), often feature high respiratory drive, determining large inspiratory efforts resulting in high pressures and global and regional over-distention, leading to lung injury. SARS-CoV-2 neurotropic-penetration in control centers in medulla oblongata might contribute to dysregulation and to excessively high respiratory drive observed in these patients. These pathophysiological conditions may often lead to the development of patient-ventilator asynchronies in aptients under mechanical ventilation, again leading to high tidal volumes and increased lung injury. These phenomena can contribute to prolonged duration of mechanical ventilation and ICU length of stay, but also can result in long term adverse outcomes like emotional/psychological and cognitive sequelae. All them compromising the quality of life of critically ill survivors after ICU discharge.

The investigators will conduct a multicenter study in adult critically ill COVID-19 patients with hypoxemic respiratory failure, aiming to: 1) characterize incidence and clustering of high respiratory drive by developing algorithms, 2) apply artificial intelligence in respiratory signals to identify potentially harmful patient-ventilator interactions, 3) characterize cognitive and emotional sequelae in critically ill COVID-19 survivors after ICU discharge and 4) identify sets of genes and transcriptomic signatures whose quantified expression predisposed to asynchronies and cognitive impairment in critically ill COVID-19 patients.

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

  • Adults patients with hypoxemic respiratory failure.
  • Admitted to ICU.
  • Mechanical ventilation or high flow nasal cannula

排除标准

  • Neurologic patients with brainsteam affection.

结局指标

主要结局

Respiratory drive

时间窗: From day 1 at ICU until the day were the criteria of PaFi > 300 is met, up to 30 days

To characterize the high respiratory drive phenomena in critically ill COVID-19 patients undergoing mechanical ventilation.

次要结局

  • Cluster of high respiratory drive(From day 1 of mechanical ventilation until the day of mechanical ventilation discontinuation, up to 30 days)
  • Artificial intelligence algorithms(From day 1 of mechanical ventilation until the day of mechanical ventilation discontinuation, up to 30 days)
  • Neurocognitive disorders(1 month after ICU discharge and 1 year after ICU discharge)
  • Gene expression(day 1 of ICU admission)

研究者

发起方
Corporacion Parc Tauli
申办方类型
Other
责任方
Principal Investigator
主要研究者

Candelaria de Haro

Medical doctor and Doctor of Philosophy

Corporacion Parc Tauli

研究点 (3)

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