Precision Ventilation vs Standard Care for Acute Respiratory Distress Syndrome (NCT06066502) | Clinical Trial Compass
RecruitingPhase 3
Precision Ventilation vs Standard Care for Acute Respiratory Distress Syndrome
United States1,100 participantsStarted 2024-06-24
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
β. Age β₯ 18 years
β. Moderate or severe ARDS, defined as meeting all of the following (a-e):
β. Invasive ventilation with positive end-expiratory pressure (PEEP) β₯ 5 cm H2O
β. Hypoxemia as characterized by: β’ If arterial blood gas (ABG) available: the partial pressure of oxygen in the arterial blood (PaO2)/FiO2 β€ 200 mm Hg, or, β’ if ABG not available OR overt clinical deterioration in oxygenation since last ABG: SpO2/FiO2 β€ 235 with SpO2 β€ 97% (both conditions) on two representative assessments between 1 to 6 hours apart. β’ If patient is positioned prone or receiving inhaled pulmonary vasodilator at time of screening:
β. Bilateral lung opacities on chest imaging not fully explained by effusions, lobar collapse, or nodules
β. Respiratory failure not fully explained by heart failure or fluid overload
β. Onset within 1 week of clinical insult or new/worsening symptoms
β. Early in ARDS course
Exclusion criteria
β. Esophageal manometry already in use clinically
β. Severe brain injury: including suspected elevated intracranial pressure, cerebral edema, or Glasgow coma score (GCS) β€ 8 directly caused by severe brain injury (e.g., ischemia or hemorrhage)
β. Gross barotrauma or chest tube inserted to treat barotrauma (note: chest tube inserted strictly for drainage of pleural effusion is not an exclusion)
β. 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
β. Ongoing severe coagulopathy (platelet \< 5000/ΞΌL or INR \> 4)
β. Extracorporeal membrane oxygenation (ECMO) or CO2 removal (ECCO2R)
β. 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)