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Comparison of Different PEEP Strategies in Moderate-to-Severe ARDS Based on Various Bedside Assessment Tools (OPTI-PEEP)

2026年7月28日 更新者:Centre Hospitalier Universitaire de Nice

Comparison of Different PEEP Strategies in Moderate-to-Severe Acute Respiratory Distress Syndrome (ARDS) Based on Various Bedside Assessment Tools

Many patients admitted to the intensive care unit (ICU) for a severe lung disease called acute respiratory distress syndrome (ARDS) require mechanical ventilation and positive end-expiratory pressure (PEEP) to improve their oxygenation. Ventilator settings-and particularly the level of PEEP-are critical in the management of these patients. In fact, inappropriate ventilator settings can lead to a worsening of the patients' lung disease or compromise their hemodynamic status.

PEEP is a pressure maintained by the ventilator during the patient's exhalation to keep the alveoli open throughout the respiratory cycle. When PEEP is increased, if many alveoli open, this is called alveolar recruitment, which is the expected beneficial effect. However, in some patients, increasing PEEP can cause already-open alveoli to become overdistended without opening new alveoli; this is known as pulmonary overdistension. This phenomenon of overdistension will worsen the patient's pulmonary condition and may also lead to hemodynamic deterioration. To date, numerous techniques have been proposed for determining the optimal PEP level (alveolar recruitment without pulmonary overdistension) in these patients, but none can be recommended as the gold standard. The objective of our study is therefore to compare the various existing methods for determining the optimal PEEP level, in order to determine whether these methods are interchangeable and which would be the best method to use to optimize the care of these patients.

To this end, the investigators plan to conduct a prospective, observational, multicenter study in the Intensive Care Units of the Nice University Hospital and the European Hospital of Marseille. Patients on mechanical ventilation for ARDS will be included in the study, and medical and laboratory data from the electronic medical records obtained during the various PEEP measurements to determine the optimal PEEP will be analyzed.

研究概览

研究类型

介入性

注册 (估计的)

45

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

学习地点

      • Nice、法国
        • Chu De Nice
        • 接触:
        • 首席研究员:
          • Clément Saccheri, MD

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:

  • Patients on invasive mechanical ventilation
  • With moderate-to-severe ARDS :

    1. Bilateral findings on chest X-ray
    2. PaO₂/FiO₂ ratio <200 with PEEP ≥+5 cmH₂O
    3. No evidence of cardiogenic pulmonary overload
  • Patients without inspiratory effort (curare administration not required)
  • Patient already fitted with an esophageal pressure probe
  • Patient already fitted with a thoracic impedance belt
  • No objection from the patient or a family member to the processing of their clinical data

Exclusion Criteria:

  • Protected individuals, namely:

    1. Individuals receiving enhanced protection, namely minors
    2. Individuals deprived of their liberty by a judicial or administrative decision
    3. Pregnant and breastfeeding women
    4. Individuals residing in a health or social care facility
    5. Adults under legal guardianship
  • Patients with a do-not-resuscitate order or a decision to limit care
  • Patients with a pacemaker or an implantable cardioverter-defibrillator
  • Acute cor pulmonale
  • Pneumothorax or ongoing pleural/thoracic drainage
  • Patients in the prone position
  • Hemodynamic instability

    1. An increase of >30% in the norepinephrine dosage over the past 6 hours
    2. Norepinephrine dosage > 0.5 µg/kg/min
  • Patients on veno-venous ECMO

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:诊断
  • 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:研究人群
Initial PEEP level will be set according to the PEEP/FiO2 table. The PEEP level will then be adjusted to achieve a plateau pressure of 28-30 cmH₂O. After 10 minutes, various hemodynamic and respiratory variables will be recorded, and an arterial blood gas analysis will be performed to assess the patient's respiratory mechanics and oxygenation. Next, the airway opening pressure will be measured, and the patient's recruitment potential will be assessed by calculating the R/I ratio through a sudden reduction in PEP from 15 cmH₂O to 5 cmH₂O over a single respiratory cycle. Following this, PEEP will be raised back to the initial level for at least 5 minutes and then gradually reduced in 2 cmH₂O increments every 2 minutes until reaching the AOP level or a PEEP level of 5 cmH₂O. In total, the optimal PEP level will be determined using six different techniques, allowing the clinician to obtain six optimal PEP values and thus best customize the ventilator settings for each patient.

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
Level of positive end expiratory pressure
大体时间:at baseline

The primary outcome measure will be the optimal level of positive end expiratory pressure achieved with each of the methods used.

The measurement of differents optimal level of positive end expiratory pressure will be determined after the positive end expiratory pressure reduction procedure.

at baseline

次要结果测量

结果测量
措施说明
大体时间
Minimale driving pressure
大体时间:at baseline

Minimale driving pressure will be assessed at various optimal positive end expiratory pressure levels according with each of the methods used.

Determining the minimum driving pressure of differents optimal level of positive end expiratory pressure will be determined after the positive end expiratory pressure reduction procedure

at baseline
Maximum pulmonary compliance
大体时间:at baseline

Maximum pulmonary compliance will be assessed at various optimal positive end expiratory pressure levels according with each of the methods used.

Determining the maximum pulmonary compliance of differents optimal level of positive end expiratory pressure will be determined after the positive end expiratory pressure reduction procedure

at baseline

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9月1日

初级完成 (估计的)

2029年9月1日

研究完成 (估计的)

2030年1月1日

研究注册日期

首次提交

2026年7月23日

首先提交符合 QC 标准的

2026年7月28日

首次发布 (实际的)

2026年8月3日

研究记录更新

最后更新发布 (实际的)

2026年8月3日

上次提交的符合 QC 标准的更新

2026年7月28日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

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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