Precision Ventilation vs Standard Care for Acute Respiratory Distress Syndrome

Eligibility Criteria

• 1. Age ≥ 18 years
• 2. Moderate or severe ARDS, defined as meeting all of the following (a-e):
• 1. Invasive ventilation with positive end-expiratory pressure (PEEP) ≥ 5 cm H2O
• 2. Hypoxemia as characterized by: If arterial blood gas (ABG) available: the partial pressure of oxygen in the arterial blood (PaO2)/FiO2 ≤ 200 mm Hg, or, if ABG not available OR overt clinical deterioration in oxygenation since last ABG: SpO2/FiO2 ≤ 235 with SpO2 ≤ 97% (both conditions) on two representative assessments between 1 to 6 hours apart
• 3. Bilateral lung opacities on chest imaging not fully explained by effusions, lobar collapse, or nodules
• 4. Respiratory failure not fully explained by heart failure or fluid overload
• 5. Onset within 1 week of clinical insult or new/worsening symptoms
• 3. Early in ARDS course
• * Within 48 hours since meeting last moderate-severe ARDS criterion (#2 above)
• * Current invasive ventilation episode not more than 4 days duration
• * Current severe hypoxemic episode (receipt of invasive ventilation, noninvasive ventilation, or high-flow nasal cannula) not more than 10 days duration
• 1. Esophageal manometry used clinically
• 2. Severe brain injury: including suspected elevated intracranial pressure, cerebral edema, or Glasgow coma score (GCS) ≤ 8 directly caused by severe brain injury (e.g., ischemia/hemorrhage).
• 3. Gross barotrauma or chest tube inserted to treat barotrauma
• 4. Esophageal varix or stricture; recent oropharyngeal or gastroesophageal surgery; or past esophagectomy
• 5. Severe coagulopathy (platelet \< 5000/µL or international normalized ratio \[INR\] \> 4)
• 6. Extracorporeal membrane oxygenation or carbon dioxide (CO2) removal
• 7. Neuromuscular disease that impairs spontaneous breathing (including but not limited to amyotrophic lateral sclerosis, Guillain-Barré syndrome, spinal cord injury at C5 or above)
• 8. Chronic supplemental oxygen, pulmonary fibrosis, or lung transplant
• 9. Refractory shock: norepinephrine-equivalent dose ≥ 0.4 µg/kg/min or simultaneous receipt of ≥ 3 vasopressors
• 10. Severe liver disease, defined as Child-Pugh Class C
• 11. ICU admission for burn injury
• 12. Current ICU stay \> 2 weeks or hospital stay (including subacute hospitalization) \> 4 weeks
• 13. Estimated mortality \> 50% over 6 months due to underlying chronic medical condition as assessed by the study physician
• 14. Moribund patient not expected to survive 24 hours as assessed by the study physician; if cardiopulmonary resuscitation (CPR) was provided, assessment for moribund status must occur at least 6 hours after CPR was completed
• 15. Limitation on life-sustaining care, other than do-not-resuscitate, or expectation by treating clinical team that a limitation on life-sustained care will be adopted within next 24 hours.
• 16. Treating clinician refusal
• 17. Prisoner