ARDS is a pathology with mortality rates reaching 40%. Invasive ventilation, the cornerstone of ARDS management, leads to "ventilation-induced lung injury" (VILI). An approach based on pressure-controlled ventilation with unassisted spontaneous respirations (PC-SV or APRV) can limit the occurrence of VILI. Time-controlled adaptive ventilation (TCAV) is based on high mean inspiratory airway pressure, while limiting expiratory time at low pressure. TCAV has shown positive effects in experimental and observational studies. However, its efficacy and safety in patients with moderate-to-severe ARDS remains to be evaluated.
Evaluation of the efficacy of early application of TCAV compared to standard ventilation on the severity of alveolar damage leading to injury-related pulmonary edema in patients with moderate to severe ARDS After obtaining patient's consent, eligible patients will be included in this open-label, randomized controlled pilot study with stratification by minimization based on initial severity. The experimental group will be the TCAV group, where ventilator settings will be standardized. The ventilator in the standard care group will be set to volumetric mode with positive end-expiratory pressure according to the EXPRESS protocol.
The measurement of extravascular lung water will be compared on day 2 between the TCAV settings group and the standard care settings group using the PICCO system.
The TCAV setting is simple and inexpensive. In ARDS patients, the increase in injury-related pulmonary edema is a relevant marker of mortality, and its reduction could improve patients' outcomes. Our study aims to evaluate the efficacy and safety of these settings to justify a future large-scale, multicenter randomized trial.
Intensive care unit hospitalisation for ARDS with a PaO₂/FiO₂ ratio ≤ 200 mmHg and PEEP ≥ 5 cmH₂O under invasive ventilation
Criteria for community-acquired pneumonia, 2 of the following: cough, purulent sputum, chest pain, dyspnea
Onset of symptoms ≤ 7 days
Invasive ventilation initiated ≤ 24 hours
Focal ARDS defined as unilateral involvement (1 out of 4 quadrants or 2 on the same side) on imaging (chest X-ray or CT scan)
Right heart failure not related to acute pulmonary heart disease secondary to ARDS (pulmonary embolism, myocarditis, ischemic cause)
Pneumothorax, drained or undrained, with a persistent pleural air leak
COPD with significant obstructive impairment defined by the presence of chronic respiratory disease and oxygen therapy or non-invasive ventilation at home
Parallel
Invasive ventilation with the Time-controlled Adaptative Ventilation settings applied to the Airway Pressure Release Ventilation mode
Other interventionInvasive ventilation with the ventilator set on the Airway Pressure Release Ventilation mode as follows: * high pressure: initially set at the level of the plateau pressure of the volume control mode * low pressure: set at 0 cmH2O (mandatory) * time high: initially set at 3 seconds * time low: set to terminate the expiratory flow at 75% of peak expiratory flow * slope: 0
Volume Control
Other interventionInvasive ventilation with the ventilator set on the Volume control mode as follows: * Tidal volume (VT) set at 6 ml/kg of predicted body weight * Positive end-expiratory pressure (PEEP) set according to the low PEEP/FiO2 table
Extravascular Lung Water (EVLW)
Measured with transpulmonary thermodilution (TPTD) and expressed in ml per kilogram of body weight
Mortality
Occurrence of death
Ventilator-free days
Number of days without invasive or non-invasive ventilation
Major Adverse Kidney Events (MAKE)
Need of dialysis, decrease ≥ 25% of glomerular filtration rate and all cause-death
Adverse Events
Defined as: * Worsening hypoxemia (increase in FiO₂ of more than 40%) within the first 30 minutes after randomization * Development of a pneumothorax with a persistent air leak * Persistent hemodynamic instability * Cardiac Index \< 2 L/min/m², * Increase in norepinephrine bitartrate dose \> 1 µg/kg/min * Persistent acute cor pulmonale * Presence of a patent foramen ovale during the first 48 hours after randomization * Severe Hypoxemia * Severe Acidosis and low tidal volume in the TCAV group * Implementation of VV-ECMO or VA-ECMO * Tidal volumes exceeding 8 mL/kg of ideal body weight
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