Early PP Monitored by EIT in Patients With ARDS

Официальное название

Early Prone Positioning Monitored by Electrical Impedance Tomography in Patients With Acute Respiratory Distress Syndrome

Обзор

Acute Respiratory Distress Syndrome (ARDS) is a syndrome characterized by respiratory distress and refractory hypoxemia caused by pulmonary and extra-pulmonary factors. Despite improvements in diagnosis and treatment in recent years, the mortality rate of severe ARDS is still around 40%. The distribution of lung lesions in ARDS patients is significantly gravity-dependent. Even with lung-protective ventilation strategies, tidal volume is concentrated in the ventral lung region, leading to ventilator-associated lung injury. Prone position ventilation can increase ventilation to the dorsal lung tissue and improve the ventilation-perfusion ratio, thus improving oxygenation. During prone position ventilation in ARDS patients, lung-protective ventilation strategies should be maintained, but with different respiratory mechanics from the supine position, requiring adjustment of ventilator parameters. Electrical Impedance Tomography (EIT) technology can be used for bedside monitoring of mechanically ventilated patients, providing real-time feedback on the patient's ventilation status and having great potential for clinical applications. Investigators believes that EIT monitoring during prone position ventilation in ARDS patients can individualize lung-protective ventilation strategies, minimize alveolar overdistension and collapse, improve the weaning success rate of invasive ventilation, and ultimately improve patient prognosis.

Вмешательства

• Процедура EIT-guided mechanical ventilation strategy
  During prone ventilation, the PEEP level is adjusted based on EIT monitoring. The optimal PEEP is the lowest sum of collapse and overdistension percentages
• Процедура Lung protective ventilation group
  Lung-protective ventilation strategy during prone positioning that continues the supine position.

Первичные конечные точки

• 28-day weaning rate from invasive mechanical ventilation [Срок оценки: At 28 days of hospitalization.]

Критерии участия

Критерии включения

• Age ≥ 18 years old；
• Meets the diagnostic criteria for ARDS according to the 2012 Berlin definition；
• Intubation with invasive mechanical ventilation time < 36 hours；
• PaO2/FiO2 < 150mmHg.

Критерии исключения

• Contraindication to the prone position;
• Contraindication to the EIT;
• Patients have received extracorporeal membrane oxygenation treatment.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Chao-Yang Hospital — Пекин

Публикации

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• Terragni PP, Rosboch G, Tealdi A, Corno E, Menaldo E, Davini O, Gandini G, Herrmann P, Mascia L, Quintel M, Slutsky AS, Gattinoni L, Ranieri VM. Tidal hyperinflation during low tidal volume ventilation in acute respiratory distress syndrome. Am J Respir Crit Care Med. 2007 Jan 15;175(2):160-6. doi: 10.1164/rccm.200607-915OC. Epub 2006 Oct 12. PMID 17038660
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Идентификаторы

NCT: NCT05822869 · 2022-KE-616

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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