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Идёт набор NCT06438198

Early Switch from Controlled to Assisted Ventilation

Без фазы С лечением Acute Hypoxemic Respiratory Failure Mechanical Ventilation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Pre-specified switch from controlled to assisted ventilation when PaO2/FiO2-ratio > 200 mmHg.
Кому может быть актуально
Состояния в реестре: Acute Hypoxemic Respiratory Failure, Mechanical Ventilation. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Нидерланды
Следующий шаг
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Официальное название

Unraveling the (patho)physiological Mechanisms and Potential Clinical Benefits of an Early Switch from Controlled to Assisted Ventilation

Обзор

The goal of this physiological intervention study is to unravel the (patho)physiological mechanisms and potential clinical benefits of a pre-specified early switch from controlled to assisted ventilation in mechanically ventilated adult patients with acute hypoxemic respiratory failure (PaO2/FiO2 ratio \< 200 mmHg). The intervention is that participants will be switched from controlled to assisted ventilation when PaO2/FiO2 ratio \> 200 mmHg. The primary endpoint is the change in regional lung stress (as derived by electrical impedance tomography) when switching from controlled to assisted ventilation and until a successful or failed switch.

Подробное описание

A crucial milestone in the trajectory of the mechanically ventilated patient is the switch from fully controlled mechanical ventilation to assisted ventilation. This switch should be made as early as feasible and safe, to limit the detrimental effects from prolonged controlled ventilation and sedation. However, there is also indirect evidence that excessive breathing effort during assisted ventilation may worsen lung injury (P-SILI). There are no guidelines that address this important switch moment.

Therefore, the overall aim of this physiological intervention study is to unravel the (patho)physiological mechanisms and potential clinical benefits of a pre-specified early switch from controlled to assisted ventilation in mechanically ventilated adult patients with acute hypoxemic respiratory failure (PaO2/FiO2 ratio \< 200 mmHg).

Participants will be switched from controlled to assisted ventilation switch when PaO2/FiO2 ratio \> 200 mmHg and will be monitored continuously using electrical impedance tomography, and oesophageal and gastric pressure until 4 hours post-switch and twice daily for 72 hours or until switch failure (switch back to controlled ventilation within 72 hours).

The primary endpoint is the change in regional lung stress (as derived by electrical impedance tomography) when switching from controlled to assisted ventilation and until a successful or failed switch.

Вмешательства

  • Другое Pre-specified switch from controlled to assisted ventilation when PaO2/FiO2-ratio > 200 mmHg
    A pre-specified switch from controlled to assisted ventilation will be initiated when PaO2/FiO2-ratio \> 200 mmHg. The moment of switch is pre-specified but patient management and ventilator settings are up to the clinical team. Switch is complete when the patient triggers all breaths spontaneously. Switch success is defined if patient reaches 72 hours on assisted ventilation. Switch failure is defined if patient switches back to controlled ventilation for more than 2 hours before 72 hours.

Первичные конечные точки

  • Regional lung stress [Срок оценки: 72 hours]
Вторичные конечные точки (11)
  • Electrical Impedance Tomography (EIT) parameters [Срок оценки: 72 hours]
  • Photon-Counting Computed Tomography (PCCT)-derived ventilation/perfusion mismatch [Срок оценки: 30 minutes]
  • Electrical Impedance Tomography (EIT)-derived ventilation/perfusion mismatch [Срок оценки: 30 minutes]
  • Respiratory mechanics [Срок оценки: 72 hours]
  • Breathing effort [Срок оценки: 72 hours]
  • Patient-ventilator asynchrony [Срок оценки: 72 hours]
  • Gas exchange [Срок оценки: 72 hours]
  • Hemodynamics [Срок оценки: 72 hours]
  • Blood inflammatory biomarkers [Срок оценки: 72 hours]
  • Breath condensate inflammatory biomarkers [Срок оценки: 72 hours]
  • Ventilator-free days [Срок оценки: 28 days]

Критерии участия

Критерии включения

  • 18 years old
  • Written informed consent from a legal representative
  • Mechanical ventilation via an endotracheal tube
  • Acute hypoxemic respiratory failure with PaO2/FiO2 ratio < 200 mmHg
  • Under continuous sedation with or without paralysis

Критерии исключения

  • Expected mechanical ventilation duration of <48 hours
  • Pure chronic obstructive pulmonary disease exacerbation
  • Pre-existent respiratory muscle disease
  • Contraindication to EIT monitoring (as per clinical protocol, e.g. pacemaker, burns or thoracic wounds limiting electrode placement)
  • Contra-indications to oesophageal manometry (as per clinical protocol, e.g., recent oesophageal surgery, oesophageal varices, severe bleeding disorders)
  • Known pregnancy
  • Anticipating withdrawal of life support and/or shift to palliation as the goal of care

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

Нидерланды · 1 центр
  • Erasmus MC — Rotterdam

Идентификаторы

NCT: NCT06438198 · MEC-2024-0011

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗