High PEEP in Noninvasive Ventilation Patients With Pneumonia or ARDS

Официальное название

Effect of High Versus Low Positive End-Expiratory Pressure on Intubation-Free Survival in Patients With Pneumonia or ARDS Receiving Noninvasive Ventilation: A Multicenter Randomized Controlled Trial

Обзор

Noninvasive ventilation is commonly employed in patients with pneumonia or acute respiratory distress syndrome (ARDS) and has been shown to reduce the need for intubation and invasive mechanical ventilation. However, the rate of noninvasive ventilation failure remains substantial, at approximately 40%. Compared with patients in whom noninvasive ventilation succeeds, those who experience noninvasive ventilation failure have a higher likelihood of mortality during their intensive care unit or hospital stay. Therefore, improving the success rate of noninvasive ventilation is clinically important. In patients with lung consolidation receiving invasive mechanical ventilation, high positive end-expiratory pressure (PEEP) can improve oxygenation. Noninvasive ventilation operates on similar physiological principles and can also deliver high PEEP via a mask interface. Nevertheless, there is limited evidence regarding the use of high PEEP during mask-delivered noninvasive ventilation. This study aimed to evaluate whether high PEEP can increase intubation-free survival in patients with pneumonia or ARDS who are treated with noninvasive ventilation.

Вмешательства

• Процедура The level of PEEP during noninvasive ventilation
  In patients receiving noninvasive ventilation, participants will be randomly assigned to either a low or a high PEEP group. In the high PEEP group, PEEP will be set between 10 and 15 cmH2O. In the low PEEP group, PEEP will be maintained at 5 cmH2O.

Первичные конечные точки

• 28-day intubation-free survival [Срок оценки: from randomization to 28 days after randomization]

Вторичные конечные точки (11)

• 28-day intubation rate [Срок оценки: from randomization to 28 days after randomization]
• the need for intubation within 28 days [Срок оценки: from randomization to 28 days after randomization]
• 28-day survival [Срок оценки: from randomization to 28 days after randomization]
• 7-category ordinal scale for clinical improvement at 28 days [Срок оценки: from randomization to 28 days after randomization]
• 28-day invasive ventilator-free days [Срок оценки: from randomization to 28 days after randomization]
• 28-day noninvasive ventilator days [Срок оценки: from randomization to 28 days after randomization]
• Length of ICU stay [Срок оценки: up to 24 weeks]
• Length of hospital stay [Срок оценки: up to 24 weeks]
• ICU mortality [Срок оценки: up to 24 weeks]
• Hospital mortality [Срок оценки: up to 24 weeks]
• 60-day mortality [Срок оценки: from randomization to 60 days after randomization]

Критерии участия

Критерии включения

• Age >18 years
• PaO2/FiO2 ≤300 mmHg or SpO2/FiO2 ≤315（SpO2 ≤97%)
• Anticipated NIV duration > 12 h
• Preserved consciousness (GCS≥13)

Критерии исключения

• Use of NIV > 24 h before randomization
• Acute-on-chronic respiratory failure
• Congestive heart failure
• Use of NIV after extubation (within 48 hours)
• Contraindications to NIV (e.g., anatomical malformations, recent pulmonary/esophageal surgery \[within 7 days\])
• Pneumothorax
• NIV intolerance
• Refusal to participate
• Pregnancy
• Need for emergency intubation

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

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Chongqing Medical University — Чунцин

Идентификаторы

NCT: NCT07298889 · ChongqingMU06

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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