Status:
RECRUITING
Precision Ventilation vs Standard Care for Acute Respiratory Distress Syndrome
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
NYU Langone Health
Massachusetts General Hospital
Conditions:
Acute Respiratory Distress Syndrome
Respiratory Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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). Particip...
Detailed Description
ARDS is a devastating condition that places a heavy burden on public health resources. Recent changes in the practice of mechanical ventilation have improved survival in ARDS, but mortality remains un...
Eligibility Criteria
Inclusion
- 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. • 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 PEEP increase may be used for eligibility determination if recorded within this 12-hour window.
- 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
- Full criteria for moderate-severe ARDS (#2 above) first met within previous 3 days
- 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
- 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 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
- Ongoing severe coagulopathy (platelet \< 5000/μL or INR \> 4)
- Extracorporeal membrane oxygenation (ECMO) or CO2 removal (ECCO2R)
- Neuromuscular disease that impairs spontaneous breathing (including but not limited to amyotrophic lateral sclerosis, Guillain-Barré syndrome, spinal cord injury at C5 or above)
- 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)
- Severe shock: norepinephrine-equivalent dose ≥ 0.6 μg/kg/min or simultaneous receipt of ≥ 3 vasopressors
- Severe liver disease, defined as Child-Pugh Class C (Section 12.3)
- ICU admission for burn injury
- Current ICU stay \> 2 weeks or acute care hospital stay \> 4 weeks
- Estimated mortality \> 50% over 6 months due to underlying chronic medical condition (e.g. metastatic pancreatic cancer) 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
- 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.
- Treating clinician refusal or unwilling to use protocol-specified ventilator settings/modes
- Prisoner
- Previous enrollment in this trial
Key Trial Info
Start Date :
June 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2030
Estimated Enrollment :
1100 Patients enrolled
Trial Details
Trial ID
NCT06066502
Start Date
June 24 2024
End Date
August 31 2030
Last Update
June 25 2025
Active Locations (24)
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1
University of Arizona
Tucson, Arizona, United States, 85724
2
University of California, San Diego
La Jolla, California, United States, 92093
3
University of California, Los Angeles Medical Center
Los Angeles, California, United States, 90024
4
Cedar-Sinai Medical Center
Los Angeles, California, United States, 90048