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Идёт набор NCT06024993

Dead Space in Mechanical Ventilation With Constant Expiratory Flow

Без фазы С лечением Mechanical Ventilation Artificial Respiration

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: Flow-controlled ventilation (FCV), Conventional volume-controlled ventilation (VCV).
Кому может быть актуально
Состояния в реестре: Mechanical Ventilation, Artificial Respiration. Базовые параметры: 18 лет — 70 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
Бельгия
Следующий шаг
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Обзор

Conventional continuous mandatory mechanical ventilation relies on the passive recoil of the chest wall for expiration. This results in an exponentially decreasing expiratory flow. Flow controlled ventilation (FCV), a new ventilation mode with constant, continuous, controlled expiratory flow, has recently become clinically available and is increasingly being adopted for complex mechanical ventilation during surgery. In both clinical and pre-clinical settings, an improvement in ventilation (CO2 clearance) has been observed during FCV compared to conventional ventilation. Recently, Schranc et al. compared flow-controlled ventilation with pressure-regulated volume control in both double lung ventilation and one-lung ventilation in pigs. They report differences in dead space ventilation that may explain the improved CO2 clearance, although their study was not designed to compare dead space ventilation within the group of double lung ventilation. Dead space ventilation, or "wasted ventilation", is the ventilation of hypoperfused lung zones, and is clinically relevant, as it is a strong predictor of mortality in patients with the acute respiratory distress syndrome (ARDS) and is correlated with higher airway driving pressures which are thought to be injurious to the lung (lung stress). This trial aims to study the difference in dead space ventilation between conventional mechanical ventilation in volume-controlled mode and flow controlled-ventilation.

Вмешательства

  • Устройство Flow-controlled ventilation (FCV)
    20 minutes of FCV, delivered with the CE-marked Evone ventilator (Ventinova medical, the Netherlands)
  • Устройство Conventional volume-controlled ventilation (VCV)
    20 minutes of conventional VCV, delivered with the CE-marked Aisys CS3 (GE Healthcare, USA) or Flow-i (Getinge, Sweden) ventilators.

Первичные конечные точки

  • Change in Bohr dead space ventilation (VDBr/VT) [Срок оценки: During FCV and VCV measurements (20 minutes)]
Вторичные конечные точки (12)
  • Change in Enghoff dead space ventilation (VDEng/VT) [Срок оценки: During FCV and VCV measurements (20 minutes)]
  • Change in physiological dead space volume (Vdfys) [Срок оценки: During FCV and VCV measurements (20 minutes)]
  • Change in airway dead space volume (Vdaw) [Срок оценки: During FCV and VCV measurements (20 minutes)]
  • Change in alveolar dead space volume (Vdalv) [Срок оценки: During FCV and VCV measurements (20 minutes)]
  • Ventilatory efficiency (VE/VCO2) [Срок оценки: During FCV and VCV measurements (20 minutes)]
  • Change in airway driving pressure (∆Paw) [Срок оценки: During FCV and VCV measurements (20 minutes)]
  • Change in transpulmonary shunt fraction (Qs/Qt) [Срок оценки: During FCV and VCV measurements (20 minutes)]
  • Change in global lung hyperdistention (hyperdistentionEIT) [Срок оценки: During FCV and VCV measurements (20 minutes)]
  • Change in anterio-posterior distribution of ventilation on EIT (AP) [Срок оценки: During FCV and VCV measurements (20 minutes)]
  • Change in right-left distribution of ventilation on EIT (RL) [Срок оценки: During FCV and VCV measurements (20 minutes)]
  • Change in 4-layered distribution of ventilation on EIT [Срок оценки: During FCV and VCV measurements (20 minutes)]
  • Change in centre of ventilation on EIT [Срок оценки: During FCV and VCV measurements (20 minutes)]

Критерии участия

Критерии включения

  • Adults \[18-70\] yrs
  • General anaesthesia for elective surgery
  • Arterial line, central venous line and endotracheal tube as part of standard of care
  • Expected duration of controlled mechanical ventilation ≥ 60 minutes
  • Supine position (0±10°)

Критерии исключения

  • One lung ventilation
  • Known pregnancy
  • Increased intra-abdominal pressure (pneumoperitoneum or obesity (BMI > 30kg/m2))
  • COPD GOLD IV or home oxygen dependence
  • Cardiac pacemaker, implantable cardioverter-defibrillator (ICD) or thoracic neurostimulator
  • Skin lesions (e.g. injury, inflammation) at the level where the Electrical Impedance Tomography (EIT) band is to be applied
  • Clinical signs of raised intracranial pressure
  • Potential interference with the surgery due to the setup of the study instruments.
  • Patient refusal to participate

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Двойное слепое
Основная цель
Фундаментальное исследование

Центры проведения

Бельгия · 1 центр
  • Antwerp University Hospital (UZA) — Edegem

Идентификаторы

NCT: NCT06024993 · 003029

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗