Precision Ventilation vs Standard Care for Acute Respiratory Distress Syndrome
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeth Israel Deaconess Medical Center
About this trial
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.
Eligibility criteria
Qualifiers
Age ≥ 18 years
Invasive ventilation with positive end-expiratory pressure (PEEP) ≥ 8 cm H2O or FiO2 ≥ 0.5
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
Disqualifiers
Esophageal manometry already in use 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 or hemorrhage)
Gross barotrauma or chest tube inserted to treat barotrauma (note: chest tube inserted strictly for drainage of pleural effusion is not an exclusion)
Esophageal pathology that, in judgement of the site investigator, significantly increases risk of esophageal catheter placement, including high-risk esophageal varices, recent oropharyngeal or gastroesophageal surgery; or past esophagectomy
Trial design
Treatments tested in this trial
- Precision ventilation
- Guided usual care ventilation
Treatment groups
1,100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Beth Israel Deaconess Medical Center
Lead sponsor
NYU Langone Health
Collaborator
Massachusetts General Hospital
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov