Combined Strategy Using Automated Subglottic Secretion Drainage and Continuous Cuff Pressure Monitoring to Prevent Microaspiration: a Multicenter Randomized Controlled Trial.

Официальное название

Combined Strategy to Prevent Microaspiration (CoSMic): Impact of the Combination of Automated Subglottic Secretion Drainage and Continuous Cuff Pressure Monitoring on the Incidence of Abundant Microaspiration of Gastric or Oropharyngeal Secretions in Mechanically Ventilated Critically Ill Patents: a Multicenter Randomized Controlled Trial.

Обзор

This trial will study the impact of a combined strategy to prevent microaspiration of oropharyngeal secretions or gastric content using automated subglottic secretion drainage and/or continuous cuff pressure monitoring. These measures aim at preventing secretions of oropharyngeal or gastric origin from entering lower respiratory tracts of patients under invasive mechanical ventilation in intensive care units (ICU), referred to as microaspiration, in the hope of preventing ventilator-associated pneumonia, a condition associated with patient outcome worsening. Patients will be randomly assigned to one of four groups: a combined strategy group using both automated techniques, 2 groups using either one or the other automated technique, and a control group using standard of care. Microaspiration will be detected by measuring concentration of oropharyngeal (amylase) or gastric (pepsin) enzymes in tracheal aspirates.

Подробное описание

Subglottic secretion drainage will be performed using an automated bedside device. Cuff pressure will be monitored manually.

Вмешательства

• Процедура Combined strategy
  Subglottic secretion drainage and cuff pressure monitoring will be performed using automated bedside devices
• Процедура Automated subglottic secretion drainage
  Subglottic secretion drainage will be performed using an automated bedside device. Cuff pressure will be monitored manually.
• Процедура Automated continuous cuff pressure monitoring
  Tracheal cuff pressure will be monitored continuously using an automated bedside device. Subglottic secretion drainage will be performed manually
• Процедура Control group
  Both tracheal cuff pressure monitoring and subglottic secretion drainage will be performed manually and discontinuously

Первичные конечные точки

• Frequency of global abundant microaspiration [Срок оценки: 48 hours after inclusion]

Вторичные конечные точки (4)

• Ventilator-associated pneumonia incidence [Срок оценки: 28 days]
• Duration of mechanical ventilation [Срок оценки: 28 days]
• ICU length of stay [Срок оценки: 28 days]
• Mortality [Срок оценки: 28 days]

Критерии участия

Критерии включения

Adult patients (> 18 years-old) admitted to the ICU Mechanical ventilation duration expected to be > 48 h Intubated with a tracheal tube allowing subglottic secretion drainage

Критерии исключения

Ongoing pregnancy Patients lacking health insurance Patients lacking legal capacity Moribund patients (expected to die in the first 24 h of ICU stay) Patients with specific oropharyngeal conditions (e.g. severe soft tissue infections of the neck, pharyngeal or laryngeal surgery, history of larynx or pharynx irratidation)

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

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07555236 · 2023_0735 · ID RCB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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