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临床试验/NCT07741916
NCT07741916尚未招募不适用

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

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2026年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
45
试验地点
1
主要终点
Level of positive end expiratory pressure

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • Patients on invasive mechanical ventilation
  • With moderate-to-severe ARDS :
  • Bilateral findings on chest X-ray
  • PaO₂/FiO₂ ratio <200 with PEEP ≥+5 cmH₂O
  • 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

排除标准

  • Protected individuals, namely:
  • Individuals receiving enhanced protection, namely minors
  • Individuals deprived of their liberty by a judicial or administrative decision
  • Pregnant and breastfeeding women
  • Individuals residing in a health or social care facility
  • 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
  • An increase of >30% in the norepinephrine dosage over the past 6 hours
  • Norepinephrine dosage > 0.5 µg/kg/min
  • Patients on veno-venous ECMO

结局指标

主要结局

Level of positive end expiratory pressure

时间窗: 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.

次要结局

  • Minimale driving pressure(at baseline)
  • Maximum pulmonary compliance(at baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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