← Back to Clinical Trials
Recruiting Phase 3 NCT06066502

Precision Ventilation vs Standard Care for Acute Respiratory Distress Syndrome

Trial Parameters

Condition Acute Respiratory Distress Syndrome
Sponsor Beth Israel Deaconess Medical Center
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 1,100
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-06-24
Completion 2029-10-01
Interventions
Precision ventilationGuided usual care ventilation

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.

Eligibility Criteria

Inclusion 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. • If patient is positioned prone or receiving inhaled pulmonary vasodilator at time of screening: Qualifying PaO2/FiO2 or SpO2/FiO2 (as defined above) that was recorded within the 6 hours immediately prior to initiating either of these therapies may be used for eligibility determination. • If PEEP has been increased by \> 5 cm H2O within the last 12 hours immediately prior to screening: Qualifying PaO2/FiO2 or SpO2/FiO2 (as defined above) prior to

Related Trials