Personalized Tidal Volume in ARDS (VT4HEMOD)

Официальное название

Personalized Tidal Volume According to Cardiopulmonary Interactions in ARDS

Обзор

Treatment of acute respiratory distress syndrome (ARDS) relies on invasive mechanical ventilation with supposedly protective settings (low tidal volume ventilation). Mortality of ARDS remains high in observational studies (40 to 50%). Approximately 30% of ARDS patients exhibit tidal hyperinflation despite low tidal volume ventilation, suggesting that personalization of tidal volume is required to improve ARDS prognostic. To date, reliable bedside tools to adjust tidal volume are lacking. Excessive tidal volume can be detected using computed tomography by quantification of tidal hyperinflation, but this technique is reserved to research studies and requires patient transport to imaging facility. Mechanical ventilation generates cardio-pulmonary interaction, whose magnitude is influenced by tidal volume and respiratory system characteristics. Pulse pressure variation is a bedside tool with potential to quantify cardio-pulmonary interactions. Increasing tidal volume will decrease right ventricular preload and increase right ventricular afterload, hence maximizing cardio-pulmonary interactions. The investigators hypothesize that pulse pressure variation might help to detect excessive tidal volume during a tidal volume challenge (i.e. stepwise increase in tidal volume)

Вмешательства

• Процедура Standardized ventilation
  Patient will be ventilated with tidal volume 6 mL/kg predicted body weight (PBW) and positive end-expiratory pressure (PEEP) according to the PEEP-FiO2 table of the ARMA trial. A CT scan will be performed with this ventilatory setting and the patients will be switched to the other group
• Процедура Personalized ventilation
  Patient will be ventilated with PEEP according to the PEEP-FiO2 table of the ARMA trial. Tidal volume will be selected as the tidal volume minimizing cardiopulmonary interactions as assessed on arterial pressure tracing, during a VT trial. A CT scan will be performed with this ventilatory setting and the patients will be switched to the other group.

Первичные конечные точки

• Tidal hyperinflation [Срок оценки: 5 minutes - This endpoint will be assessed 5 minutes after ventilatory adjustment]

Вторичные конечные точки (1)

• Tidal volume [Срок оценки: 5 hours - This endpoint will be assessed through study completion (approximately 4-5 hours after study inclusion)]

Критерии участия

Критерии включения

• Age greater then 18 years old
• ARDS according to the BERLIN definition with PaO2/FiO2 ratio ≤ 150 mm Hg
• invasive mechanical ventilation in volume controlled mode with tidal volume set to 6 ml/kg predicted body weight
• use of sedation and neuromuscular-blocking agents
• arterial catheter allowing computation of pulse contour cardiac output calibrated with thermodilution
• central venous catheter implanted in the superior vena cava territory
• esophageal balloon
• Computed tomography planned by attending physician

Критерии исключения

• Previous inclusion in current study
• Acute cor pulmonale
• ECMO
• Arterial pH < 7.21 despite respiratory rate set to a maximum of 35/min
• Pneumothorax or bronchopleural fistula
• Decision to withdraw or withhold life sustaining treatment with 24 hours from inclusion
• Contra-indication of transport to imaging facility
• Intracranial hypertension
• Tricuspid or pulmonary mechanical valve
• Tricuspid or pulmonary infective endocarditis
• Pace maker with intracardiac leads
• Right ventricle tumor
• Complete left bundle block
• Intrathoracic metallic device
• COPD
• Cardiac arrythmia
• Vesical pressure > 15 mm Hg
• Lower limb amputation
• Inferior vena cava thrombosis
• Patient under an exclusion period relative to participation to another clinical trial
• Patient under a legal protective measure
• Patient not affiliated to social security
• lac of patient/representative consent
• Pregnancy
• Breast feeding

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

Открытое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Hospices Civils de Lyon - Hôpital de la Croix Rousse - Service de Médecine Intensive Réani — Lyon

Идентификаторы

NCT: NCT05406570 · 69HCL21_1272 · 2021-A02996-35

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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