此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Impact and Sequelae of High Ventilatory Drive in Critically Ill COVID-19 Patients

2022年5月3日 更新者:Candelaria de Haro、Corporacion Parc Tauli

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

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.

研究概览

研究类型

观察性的

注册 (预期的)

126

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Manresa、西班牙
        • 招聘中
        • Fundacio Althaia
        • 接触:
        • 副研究员:
          • Montserrat Batlle, MD, PhD
      • Oviedo、西班牙
        • 招聘中
        • Hospital Universitario Central de Asturias
        • 接触:
          • Guilermo Muñiz-Albaiceta, PhD
          • 电话号码:985 10 80 00
          • 邮箱gma@cri-lab.org
    • Barcelona
      • Sabadell、Barcelona、西班牙、08208
        • 招聘中
        • Candelaria De Haro
        • 接触:
          • Candelaria De Haro, MD, PhD
          • 电话号码:21158 0034937231010
          • 邮箱cdeharo@tauli.cat
        • 首席研究员:
          • Josefina Lopez-Aguilar, PhD

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Adult patients admitted to ICU with acure respiratory failure secondary to COVID-19 infection and other etiologies.

描述

Inclusion Criteria:

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

Exclusion Criteria:

  • Neurologic patients with brainsteam affection.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
COVID-19 Cohort
Patients with a diagnosis of moderate or severe pneumonia or ARDS secondary to COVID-19.
Non COVID-19 Cohort
Patients with a diagnosis of moderate or severe pneumonia or ARDS not secondary to COVID-19.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Respiratory drive
大体时间: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.
From day 1 at ICU until the day were the criteria of PaFi > 300 is met, up to 30 days

次要结果测量

结果测量
措施说明
大体时间
Cluster of high respiratory drive
大体时间:From day 1 of mechanical ventilation until the day of mechanical ventilation discontinuation, up to 30 days
To describe the incidence and clustering of high respiratory drive throughout mechanical ventilation period by the development of specific algorithms.
From day 1 of mechanical ventilation until the day of mechanical ventilation discontinuation, up to 30 days
Artificial intelligence algorithms
大体时间:From day 1 of mechanical ventilation until the day of mechanical ventilation discontinuation, up to 30 days
To apply artificial intelligence (machine learning, deep learning, pattern/image recognition and entropy) in physiologic respiratory signals to identify potentially harmful patient-ventilator interactions.
From day 1 of mechanical ventilation until the day of mechanical ventilation discontinuation, up to 30 days
Neurocognitive disorders
大体时间:1 month after ICU discharge and 1 year after ICU discharge
To characterize cognitive and emotional sequelae in critically ill COVID-19 survivors at 1 month and 1 year after ICU discharge.
1 month after ICU discharge and 1 year after ICU discharge
Gene expression
大体时间:day 1 of ICU admission
Application of massive sequencing of gene expression and circulating micro-RNA in blood samples to identify sets of genes and c-miRNA whose quantified expression is related to ventilatory asynchronies and cognitive and emotional impairment in critically ill COVID-19 patients.
day 1 of ICU admission

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年11月15日

初级完成 (预期的)

2023年5月15日

研究完成 (预期的)

2024年11月15日

研究注册日期

首次提交

2022年4月29日

首先提交符合 QC 标准的

2022年5月3日

首次发布 (实际的)

2022年5月5日

研究记录更新

最后更新发布 (实际的)

2022年5月5日

上次提交的符合 QC 标准的更新

2022年5月3日

最后验证

2022年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

新冠肺炎的临床试验

3
订阅