Precision Ventilation vs Standard Care for Acute Respiratory Distress Syndrome

About

Brief Summary

The goal of this interventional study is to compare standard mechanical ventilation to a lung-stress oriented ventilation strategy in patients with Acute Respiratory Distress Syndrome (ARDS). Participants will be ventilated according to one of two different strategies. The main question the study hopes to answer is whether the personalized ventilation strategy helps improve survival.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 3

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

Inclusion Criteria:

Age ≥ 18 years
Moderate or severe ARDS, defined as meeting all of the following (a-e):
- Invasive ventilation with positive end-expiratory pressure (PEEP) ≥ 5 cm H2O
- 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
- Bilateral lung opacities on chest imaging not fully explained by effusions, lobar collapse, or nodules
- Respiratory failure not fully explained by heart failure or fluid overload
- Onset within 1 week of clinical insult or new/worsening symptoms
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

Exclusion Criteria:

Esophageal manometry used clinically
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).
Gross barotrauma or chest tube inserted to treat barotrauma
Esophageal varix or stricture; recent oropharyngeal or gastroesophageal surgery; or past esophagectomy
Severe coagulopathy (platelet < 5000/µL or international normalized ratio [INR] > 4)
Extracorporeal membrane oxygenation or carbon dioxide (CO2) removal
Neuromuscular disease that impairs spontaneous breathing (including but not limited to amyotrophic lateral sclerosis, Guillain-Barré syndrome, spinal cord injury at C5 or above)
Chronic supplemental oxygen, pulmonary fibrosis, or lung transplant
Refractory shock: norepinephrine-equivalent dose ≥ 0.4 µg/kg/min or simultaneous receipt of ≥ 3 vasopressors
Severe liver disease, defined as Child-Pugh Class C
ICU admission for burn injury
Current ICU stay > 2 weeks or hospital stay (including subacute hospitalization) > 4 weeks
Estimated mortality > 50% over 6 months due to underlying chronic medical condition as assessed by the study physician
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
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.
Treating clinician refusal
Prisoner