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A Study of the Determinants of Neurological Outcomes in Patients With Acute Respiratory Distress Syndrome (NEURDS)

2026年7月24日 更新者:University Hospital, Angers

Etude Des déterminants de l'évolution NEUrologique Des Patients Ayant présenté un Syndrome de Détresse Respiratoire aiguë

Acute respiratory distress syndrome (ARDS) is characterized by pathological pulmonary edema caused by direct or indirect damage to the alveolar-capillary membrane.

Its management relies on etiological treatment, invasive mechanical ventilation, and the use of sedatives and neuromuscular blockers, depending on the patient's condition.

Improvements in patient care have led to an improved prognosis. However, in-hospital mortality remains high (between 35% and 45%). Notably, morbidity among surviving patients is very high and is largely dominated by neuropsychological sequelae. Attention and executive function disorders, confusion, disorientation, or memory impairment are thus found in 70 to 100% of patients following ARDS. These disorders are still present in 46 to 80% of surviving patients one year after ARDS and in 20% of them five years later.

Although essential to treatment, mechanical ventilation carries a risk of significant complications. Beyond the risk of infection and complications related to sedation and neuromuscular blockade, the use of mechanical ventilation is associated with a risk of ventilator-induced lung injury (VILI).

The use of so-called protective ventilation reduces the risk of VILI and improves patient outcomes. However, analysis of relevant physiological parameters shows that the risk of VILI may still exist even when ventilator settings comply with recommendations and the concept of protective ventilation. Driving pressure (which represents Strain) is a good marker of VILI; it represents the distension of the lung with each breath relative to the initial lung volume. Values above 14 cmH₂O are associated with high mortality in patients with ARDS. Inspiratory transpulmonary pressure represents Stress-that is, the pressure that distends the alveoli at the end of inspiration-and is also associated with the risk of VILI. Finally, mechanical power represents the amount of energy delivered to the lung by the ventilator and has been validated as a marker of VILI. The advantage of mechanical power over the other indices described is that it incorporates all components that can lead to VILI.

Among the various sources of neurological damage during ARDS, inflammatory processes appear to play a major role. Numerous inflammatory mediators (TNF-α, IL-6, IL-8, IL-1β) are secreted during ARDS, and animal studies have demonstrated a link between inflammation and hippocampal damage. Furthermore, cerebral ischemic lesions, exacerbated by systemic inflammation and endothelial activation leading to coagulation activation with thrombus formation, may also contribute to the development of cognitive impairments.

In addition to the inflammatory processes associated with ARDS, mechanical ventilation itself may have a significant impact on neuroinflammatory damage. Recently, the term "ventilator-associated brain injury" (VABI) has been proposed to describe these secondary neurological lesions induced by mechanical ventilation. Studies in mouse and pig models have demonstrated a relationship between the dose and duration of VILI, apoptosis, neuroinflammation, and neuronal damage. An animal study in mice also showed an association between the duration of mechanical ventilation and the onset of cognitive impairments.

During brain injury, proteins and neurotransmitters are released and serve as biomarkers of brain damage. Elevated plasma levels of S100B protein indicate astrocyte damage caused by traumatic, anoxic-ischemic, or inflammatory mechanisms. It correlates with neurological prognosis following cardiac arrest, in ischemic or hemorrhagic strokes, in neurodegenerative diseases, and in patients with traumatic brain injury.

Clinical studies have shown a negative correlation between elevated S100B protein levels, the MoCA (Montreal Cognitive Assessment) score, and the MMSE (Mini-mental state evaluation ) in patients with OSA (Obstructive Sleep Apnea) or COPD (chronic obstructive pulmonary disease), respectively, indicating an association between this protein and cognitive impairment.

The investigators therefore hypothesize that mechanical ventilation associated with high mechanical power is linked to a significant risk of brain injury, reflected by elevated serum S100B protein levels and the presence of neurocognitive disorders long after ARDS.

研究概览

研究类型

介入性

注册 (估计的)

150

阶段

  • 不适用

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。

学习联系方式

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

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Adult patient
  • Patient admitted to the intensive care unit less than 48 hours ago
  • Patient diagnosed with mild, moderate or severe ARDS according to the Berlin classification based on the PaO₂/FiO₂ ratio, with a minimum PEEP set at 5 cmH₂O (16), of pulmonary aetiology:

    • Mild ARDS: 200 < PaO₂/FiO₂ < 300 mmHg
    • Moderate ARDS: 100 < PaO₂/FiO₂ < 200 mmHg
    • Severe ARDS: PaO₂/FiO₂ < 100 mmHg
  • Patients fitted with an oesophageal pressure measurement catheter (Nutrivent, Sidam, San Giacomo Roncole, Italy)
  • Patients registered with or covered by a social security scheme
  • Free and informed consent from the patient or a trusted relative (where the patient is unable to give consent).

Exclusion Criteria:

  • Patients with a history of central nervous system disorders resulting in cognitive impairment
  • Patients on ECMO
  • Patients admitted for symptomatic central nervous system disorders
  • Patients admitted for acute respiratory distress syndrome following cardiorespiratory arrest.
  • Patients being treated for a psychiatric condition, chronic heavy drinkers, or those undergoing long-term treatment with benzodiazepines, antidepressants or antipsychotics.
  • Pregnant, breastfeeding or labouring patients
  • Individuals subject to a legal protection order
  • Individuals receiving compulsory psychiatric care
  • Individuals deprived of their liberty by judicial or administrative decision

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

  • 主要用途:其他
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:cohort
collection of oesophageal pressure data, mechanical power calculation, MOCA score collection and blood sample collection for S100B protein dosage
collection of oesophageal pressure data, mechanical power calculation, MOCA score collection and blood sample collection for S100B protein dosage

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
association between the mechanical power between Day 1 and Day 3 (reflecting the risk of VILI)
大体时间:at day 1, day 2 and day 3
mechanical power calculation
at day 1, day 2 and day 3
S-100B serum protein level between Day 1 (H0) and Day 3 (H72).
大体时间:at day 1, day 2 and day 3
S-100B protein dosage
at day 1, day 2 and day 3

次要结果测量

结果测量
措施说明
大体时间
association between serum S100B protein concentrations from day 1 to day 3 and neurological outcome at 3 months and 12 months
大体时间:at 3 and 12 months
Correlation coefficient between S-100B protein levels from Day 1 to Day 3 and the MOCA (Montreal Cognitive Assessment) score at 3 and 12 months (no neurocognitive impairment if MOCA ≥ 26/30, neurocognitive impairment if < 25/30).
at 3 and 12 months
association between other VILI markers (inspiratory transpulmonary pressure and driving pressure) and serum S100B protein concentrations from day 1 to day 3.
大体时间:From day 1 to day 3
Correlation coefficient between inspiratory transpulmonary pressure and driving pressure, and serum S-100B levels between Day 1 and Day 3, whilst accounting for potential confounding factors in a multivariate model
From day 1 to day 3
association between these other VILI markers and neurological outcomes at 3 months and 12 months.
大体时间:at 3 and 12 months
Correlation coefficient between mechanical power, inspiratory transpulmonary pressure and driving pressure (average of values measured between J1 and J3) and the MOCA score at 3 and 12 months, taking potential confounding factors into account in a multivariate model
at 3 and 12 months
association between the occurrence of delirium during a stay in the intensive care unit and neurological outcomes at 3 and 12 months.
大体时间:at 3 and 12 months
The occurrence of neurocognitive impairment, defined as a MoCA score of <25/30 at the 3- and 12-month assessments, in patients who experienced delirium in the intensive care unit compared with those who did not.
at 3 and 12 months
prevalence of depression among patients who presented ARDS
大体时间:at 3 months
occurrence of depressive symptoms defined as a Patient Health Questionnaire-9 (PHQ-9) score > 10/27
at 3 months
prevalence of post-traumatic stress (PCL-5 score) among patients who presented ARDS
大体时间:at 3 months
occurrence of post-traumatic stress defined as a Post-Traumatic Stress Disorder Checklist dor DSM-5 (PCL-5) score > 33/80
at 3 months
prevalence of anxiety among patients who presented ARDS
大体时间:at 3 months
anxiety disorders defined as a General Anxiety Disorder-2 (GAD-2) score > 3/6
at 3 months
quality of life state (Euro 5d 5l score) among patients who presented ARDS
大体时间:at 3 months
deterioration in quality of life measured with EuroQol-5D-5L (max 5 points) :score analysed both continuously and categorically
at 3 months
prevalence of independence among patients who presented ARDS
大体时间:at 3 months
occurence of a decline in functional independence defined as the loss of at least one instrumental activity compared with the level prior to hospitalisation with the Instrumental Activities of Daily Living (IADL) score (from 8 to 30 max)
at 3 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。

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 (估计的)

2026年10月17日

初级完成 (估计的)

2028年10月23日

研究完成 (估计的)

2029年10月23日

研究注册日期

首次提交

2026年6月1日

首先提交符合 QC 标准的

2026年6月1日

首次发布 (实际的)

2026年6月5日

研究记录更新

最后更新发布 (实际的)

2026年7月27日

上次提交的符合 QC 标准的更新

2026年7月24日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • 49RC25_0292

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.

IPD 共享时间框架

The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.

IPD 共享访问标准

The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).

IPD 共享支持信息类型

  • 研究方案

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

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