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急性呼吸窘迫综合征后的纵向恢复轨迹，一种新的认识 (TENACITY)

2026年11月2日更新者：Jessica González Gutiérrez MD, PhD、Institut de Recerca Biomèdica de Lleida

急性呼吸窘迫综合征后的纵向恢复轨迹，一种新的认识。坚韧研究

COVID-19 resulted in the largest cohort of critical illness survivors in history, heightened awareness of the importance of the respiratory sequelae after an acute distress respiratory syndrome (ADRS). Despite the advancement of acute-phase ARDS management, it is unknown whether there are differences in the longitudinal recovery trajectories between patients with post-ARDS due to COVID-19 and due to other causes. The main objective of the study is to identify risk factors of pulmonary sequela (lung diffusing capacity) at long-term follow-up in survivors of ARDS. The investigators are also interested in describing the long-term longitudinal recovery trajectories at a multi-dimensional level (symptoms, quality of life, neurocognitive, other lung function parameters, exercise capacity, chest imaging and molecular profiles) of ARDS survivors, and compared between ARDS caused by COVID-19. The ultimate goal is to understand the pathobiological mechanisms associated with a severe lung injury at the long term, allowing the introduction of clinical guidelines for the management of post-ARDS patients and the assignment of personalized interventions.

研究概览

地位

主动，不招人

条件

详细说明

The coronavirus disease 2019 (COVID-19) resulted in the largest cohort of critical illness survivors in history, heightened awareness of the importance of the multi-dimensional sequelae after an acute distress respiratory syndrome (ADRS). With the advancement of acute-phase ARDS management, it is unknown whether there are differences in longitudinal recovery trajectories in terms of lung function, symptoms, quality of life, neurocognitive disorders, exercise capacity, chest imaging, and even at molecular basis between patients with post-ARDS due to COVID-19 and due to other causes. This project will continue to generate information about non-COVID-19 post-ARDS based on the experience in our post-COVID consultation that began in May 2020.

The main objective of the study is to identify risk factors of pulmonary sequela in terms of DLCO at long-term follow-up in survivors of ARDS. The investigators are also interested in describing the long-term longitudinal recovery trajectories at a multidimensional level (symptoms, quality of life, neurocognitive, other lung function parameters, exercise capacity, chest imaging and molecular profiles) of ARDS survivors. Furthermore, risk factors as well as recovery trajectories will be compared between ARDS caused by COVID-19 and non-COVID-19. The ultimate goal is to understand the pathobiological mechanisms associated with a severe lung injury at the long term (one year after hospital discharge), in order to provide novel therapeutic targets to develop future intervention studies.

For doing so, adult ARDS survivors of any origin (different than COVID-19) (n=246) referred to the post-CRITICAL consultation at the University Hospitals of Arnau de Vilanova and Santa Maria (Lleida), University Hospital Joan XXIII (Tarragona) and Verge de la Cinta (Tortosa) will be included in this multicentric, prospective, longitudinal and observational study. Previous standardized protocol will be followed at 3, 6 and 12 months after hospital discharge with a complete evaluation of symptoms, neurocognitive, memory problems and quality of life. Lung function, exercise test, chest CT and molecular analysis will be performed at each time point. The prognostic factors and the longitudinal recovery trajectories of ARDS survivors will be assessed using latent class mixed and machine learning artificial models.

The specific objectives to achieve the general objective are the following:

Objective 1: To identify risk factors of lung function sequelae (spirometry, total lung volumes and lung diffusing capacity) in non-COVID-19 ARDS survivors.
Objective 2: To identify risk factors of structural pulmonary sequelae (chest CT findings) in non-COVID-19 ARDS survivors.
Objective 3: To identify risk factors of symptoms, neurocognitive disorders (BC-CCI, MOCA) and quality of life (SF-12) in non-COVID-19 ARDS survivors.
Objective 4: To develop a clinical scoring tool to predict pulmonary sequelae at short- and long-term follow-up.
Objective 5: To compare risk factors and recovery trajectories with COVID-19 ARDS survivors using data previously collected.
Objective 6: To use artificial intelligence to identify multidimensional phenotypes associated with recovery trajectories.
Objective 7: To design a cost-effective follow-up plan after hospital discharge in ARDS patients based on hospital risk factors.
Objective 8: To identify molecular profiles according to recovery trajectories in non-COVID-19 ARDS.

研究类型

观察性的

注册 (估计的)

246

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

西班牙
- Lleida
  - Lleida、Lleida、西班牙、25198
    - Hospital Universitari Arnau de Vilanova
- Tarragona
  - Tarragona、Tarragona、西班牙、43005
    - Hospital Universitari Joan XXIII
  - Tortosa、Tarragona、西班牙、43500
    - Hospital de Tortosa Verge de la Cinta

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

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Critical patients admited to the intensive care unit of the 3 participant hospitals whot meet the eligibility criteria.

描述

Inclusion Criteria:

Male and female patients aged ≥18 years
Admission to the ICU
Diagnosis of severe pneumonia and/or diagnosis of acute respiratory distress syndrome (ARDS) based on the 2023 definition due to any origin (infectious and non-infectious)

Exclusion Criteria:

Life expectancy less than a year
Transfer to another hospital during hospitalization or follow-up
Stay in palliative care
Severe mental disability that makes it impossible to carry out pulmonary function tests during follow-up

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

观测模型：COHORT
时间观点：PROSPECTIVE

团体/队列数

队列和干预

团体/队列
post-ICU with ARDS Patients admitted to the ICU who have developed Acute Respiratory Distress Syndrome (ARDS), as defined according the new 2023 guidelines (Matthay et.al, 2023)
post-ICU without ARDS Patients admitted to the ICU who have suffered a severe pneumonia, needing advanced respiratory support, but without developing ARDS according to the new 2023 guidelines.

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
Changes in lung diffusing capacity 大体时间：3, 6 and 12 months	Changes in the results of lung diffusing capacity (DLCO) in terms of mL/mmHg/MI	3, 6 and 12 months
Changes in lung diffusing capacity 大体时间：3, 6 and 12 months	Changes in the results of lung diffusing capacity (DLCO) in terms of percentage (%)	3, 6 and 12 months
Changes in lung volumes 大体时间：3, 6 and 12 months	Changes in the results of lung capacity or total lung capacity (TLC) in terms of Liters (L)	3, 6 and 12 months
Changes in lung volumes 大体时间：3, 6 and 12 months	Changes in the results of lung capacity or total lung capacity (TLC) in terms of percentage (%)	3, 6 and 12 months
Changes in chest CT findings 大体时间：3, 6 and 12 months	Identification of structural pulmonary sequelae in terms of chest CT findings	3, 6 and 12 months

次要结果测量

结果测量	措施说明	大体时间
Changes in the perceived cognitive difficulties 大体时间：3, 6 and 12 months	Changes in the results of the British Columbia Cognitive Complaints Inventory (BC-CCI) test. The scale consists of 6 items assessing perceived problems with concentration, memory, expressing thoughts, word finding, slow thinking, and difficulty solving problems in the past 7 days. Scores on each item (ranging from 0, not at all, to 3, very much) are summed to yield a total score ranging from 0 to 18; higher scores indicate greater severity of cognitive complaints.	3, 6 and 12 months
Changes in the cognitive function 大体时间：3, 6 and 12 months	Changes in the results of Montreal Cognitive Assessment (MoCA) test. The MoCA test examines seven domains of cognitive function with a total of 11 different exercises and tasks. The total score ranges from 0 to 30, lower scores indicate greater severity of cognitive impairment.	3, 6 and 12 months
Changes in the fatigue status 大体时间：3, 6 and 12 months	Changes in the results of Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale (Version 4) This scale is a short test of 13-item that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The total score range is 0-52, being the higher the score, the better the quality of life and less perception of fatigue.	3, 6 and 12 months
Changes in the levels of anxiety 大体时间：3, 6 and 12 months	Changes in the results of Hospital Anxiety and Depression Scale (HAD) The scale determines the levels of anxiety and depression that a person is experiencing. It is a 14 item scale (7 of the items relate to anxiety and 7 relate to depression). Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Lower scores indicate less anxiety or depression.	3, 6 and 12 months
Changes in independence to carry out daily activities 大体时间：3, 6 and 12 months	Changes in the results of Barthel test. Barthel Index (BI) measures the extent to which somebody can function independently and has mobility in their activities of daily living. The Index yields a total score out of 100 - the higher the score, the greater the degree of functional independence. This score is calculated by simply totaling the individual item scores.	3, 6 and 12 months
Changes in the perception of life quality 大体时间：3, 6 and 12 months	Changes in the results of 12-Item Short Form Survey (SF-12) test. The SF-12 is a self-reported outcome measure composed by 12 items which examine eight dimensions of physical and mental health. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.	3, 6 and 12 months
Validation of a clinical scoring tool 大体时间：3, 6 and 12 months	Validation of a clinical scoring tool to predict pulmonary sequelae at short- and long-term follow-up.	3, 6 and 12 months
Cost-effectiveness of a follow-up plan 大体时间：3, 6 and 12 months	Only direct costs will be considered. Analysis will include an estimation of quality-adjusted life-years (QALYs) gained	3, 6 and 12 months
Identification of molecular profiles 大体时间：3, 6 and 12 months	Classification of the population in different molecular profiles according to their recovery trajectories	3, 6 and 12 months
Multidimensional phenotypes 大体时间：3, 6 and 12 months	multidimensional phenotypes associated with recovery trajectories defined with artificial intelligence	3, 6 and 12 months
Recovery trajectories of lung diffusing capacity 大体时间：3, 6 and 12 months	Comparison of risk factors and recovery trajectories in terms of lung diffusing capacity (DLCO) with COVID-19 ARDS survivors using data previously collected.	3, 6 and 12 months
Recovery trajectories of total lung capacity 大体时间：3, 6 and 12 months	Comparison of risk factors and recovery trajectories in terms of total lung capacity (TLC) with COVID-19 ARDS survivors using data previously collected.	3, 6 and 12 months
Recovery trajectories of perception of life quality 大体时间：3, 6 and 12 months	Comparison of risk factors and recovery trajectories in terms of perception of life quality (SF12 test) with COVID-19 ARDS survivors using data previously collected.	3, 6 and 12 months
Recovery trajectories of perception of fatigue 大体时间：3, 6 and 12 months	Comparison of risk factors and recovery trajectories in terms of perception of fatigue (FACIT-4 test) with COVID-19 ARDS survivors using data previously collected.	3, 6 and 12 months

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。

赞助

Institut de Recerca Biomèdica de Lleida

合作者

Instituto de Salud Carlos III

调查人员

首席研究员：Jessica González Gutiérrez, MD, PhD、Institut de Recerca Biomèdica de Lleida

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)

2023年6月29日

初级完成 (估计的)

2027年7月1日

研究完成 (估计的)

2028年6月30日

研究注册日期

首次提交

2023年9月4日

首先提交符合 QC 标准的

2023年10月11日

首次发布 (实际的)

2023年10月16日

研究记录更新

最后更新发布 (实际的)

2026年11月4日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11月1日