Lung EIT Image Guide Ventilation in ARDS

Официальное название

Personalised EIT-guided Ventilation Strategy Versus Conventional Protective Ventilation Strategy in ARDS Patients: a Multicenter, Randomized, Controlled triaL

Обзор

The goal of this multi-center randomized controlled clinical trial is to learn if an individualized, bedside electrical impedance tomography (EIT)-guided ventilation strategy (including EIT-guided prone positioning and PEEP titration) can improve outcomes compared with a conventional lung-protective ventilation strategy in adult patients with acute respiratory distress syndrome (ARDS). The main questions it aims to answer are: Does the individualized EIT-guided ventilation strategy reduce 28-day mortality in ARDS patients? Researchers will compare the EIT-guided intervention arm to a control arm receiving routine lung-protective ventilation (without bedside EIT guidance) to see if the EIT-guided approach lowers 28-day mortality and improves other clinical outcomes. Adult ARDS patients who meet inclusion criteria will be assigned to EIT-guided group and control group through stratified randomization: EIT-guided group: Undergo bedside EIT assessments using a China-manufactured EIT device to guide decisions about prone positioning and individualized PEEP titration (including a recruitment maneuver). Control group: Receive PEEP setting per conventional PEEP-FiO₂ tables and prone positioning per standard clinical indications without EIT guidance. Both groups: Receive standard supportive ICU care and routine outcome assessments at multiple time points. Primary outcome: 28-day mortality. Other outcomes include ventilator-free days to day 28 and so on.

Вмешательства

• Другое Recruitment maneuver and PEEP setting guided by EIT
  The EIT-guided group, will receive recruitment maneuver and PEEP titration guided by EIT to determine the optimal PEEP level.
• Другое PEEP setting according to routine practice
  The control group will receive routine ventilation strategy. Routine recruitment maneuver is not recommended but may be used as rescue therapy. PEEP is set using the conventional PEEP-FiO₂ table.
• Поведенческое Prone positioning guided by EIT
  The EIT-guided group, will determine prone positioning therapy based on EIT.
• Поведенческое Prone positioning according to routine practice
  The control group will determine prone positioning therapy based on routine practice.

Первичные конечные точки

• 28-day mortality [Срок оценки: Day 28 after randomization]

Вторичные конечные точки (2)

• Ventilator-free days within 28 days after randomization [Срок оценки: within 28 days after randomization]
• Ventilator-free days within 14 days after randomization [Срок оценки: Within 14 days after randomization]

Критерии участия

Критерии включения

• Patients with ARDS receiving mechanical ventilation who meet the following diagnostic criteria:

• Triggered by acute risk factors such as pneumonia, non-pulmonary infection, trauma, transfusion, aspiration, or shock. Pulmonary edema is not entirely or predominantly attributable to cardiogenic causes or fluid overload, and hypoxemia/gas exchange impairment is not mainly due to atelectasis. However, ARDS can be diagnosed in the presence of these conditions if predisposing risk factors exist.
• Acute onset or worsening of hypoxemic respiratory failure within 1 week of the identified risk factor or onset of new or worsening respiratory symptoms.
• Bilateral opacities on chest radiograph or CT, or bilateral B-lines and/or consolidation on ultrasound, not fully explained by effusion, atelectasis, or nodules/masses.
• PaO₂/FiO₂ ≤ 300 mm Hg or SpO₂/FiO₂ ≤ 315 (if SpO₂ ≤ 97%).
• ARDS onset within 1 week.
• Mechanical ventilation ≤ 72 hours.

Критерии исключения

• Age < 18 years.
• Pregnancy.
• Contraindications to EIT application (e.g., local skin lesions, cardiac pacemaker).
• Contraindications to prone positioning (e.g., increased intracranial pressure, intra-abdominal hypertension, spinal fractures).
• Evidence of barotrauma such as pneumothorax, mediastinal emphysema, or subcutaneous emphysema.
• End-stage disease.
• Informed consent not signed by legal guardians or family.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Department of Critical Care Medicine, Peking Union Medical College Hospital, Peking Union — Пекин

Идентификаторы

NCT: NCT07309783 · PEARL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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