Precision Ventilation vs Standard Care for Acute Respiratory Distress Syndrome

Exclusion Criteria

• •1. Esophageal manometry already in use 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 or hemorrhage)
• •3. Gross barotrauma or chest tube inserted to treat barotrauma (note: chest tube inserted strictly for drainage of pleural effusion is not an exclusion)
• •4. Esophageal varix or stricture that, in judgement of the site investigator, significantly increases risk of esophageal catheter placement; recent oropharyngeal or gastroesophageal surgery; or past esophagectomy
• •5. Ongoing severe coagulopathy (platelet \< 5000/μL or INR \> 4)
• •6. Extracorporeal membrane oxygenation (ECMO) or CO2 removal (ECCO2R)
• •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. Any of the following severe chronic lung diseases: continuous home supplemental oxygen \> 3 liters/minute, pulmonary fibrosis, cystic fibrosis, lung transplant, or acute exacerbation of a chronic interstitial lung disease (ILD)
• •9. Severe shock: norepinephrine-equivalent dose ≥ 0.6 μg/kg/min or simultaneous receipt of ≥ 3 vasopressors
• •10. Severe liver disease, defined as Child-Pugh Class C (Section 12.3)
• •11. ICU admission for burn injury
• •12. Current ICU stay \> 2 weeks or acute care hospital stay \> 4 weeks
• •13. Estimated mortality \> 50% over 6 months due to underlying chronic medical condition (e.g. metastatic pancreatic cancer) 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. Current limitation on life-sustaining care (other than do-not-resuscitate), or expectation by clinical team that a limitation on life-sustained care will be adopted within next 24 hours.
• •16. Treating clinician refusal or unwilling to use protocol-specified ventilator settings/modes
• •17. Prisoner
• •18. Previous enrollment in this trial