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Compares treatment options for Acute Respiratory Distress Syndrome
Official title Precision Ventilation vs Standard Care for Acute Respiratory Distress Syndrome
ClinicalTrials.gov ID: NCT06066502
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- Ventilator-dependent ARDS, with all of the following (a-e):
- Invasive ventilation with positive end-expiratory pressure (PEEP) ≥ 8 cm H2O or FiO2 ≥ 0.5
- Hypoxemia as characterized by: If arterial blood gas (ABG) available: the partial pressure of oxygen in the arterial blood (PaO2)/FiO2 ≤ 300 mm Hg...
- Bilateral lung opacities on chest imaging not fully explained by effusions, lobar collapse, or nodules
You likely can't join if
- 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...
- 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...
- Ongoing severe coagulopathy (platelet \ 4)
- Extracorporeal membrane oxygenation (ECMO) or CO2 removal (ECCO2R)
See the full eligibility criteria
- Age ≥ 18 years
- Ventilator-dependent ARDS, with all of the following (a-e):
- Invasive ventilation with positive end-expiratory pressure (PEEP) ≥ 8 cm H2O or FiO2 ≥ 0.5
- Hypoxemia as characterized by: If arterial blood gas (ABG) available: the partial pressure of oxygen in the arterial blood (PaO2)/FiO2 ≤ 300 mm Hg, or, if ABG not available OR overt clinical deterioration in oxygenation...
- 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 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
- 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...
- Ongoing severe coagulopathy (platelet \ 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: cystic fibrosis, acute bronchiectasis exacerbation, acute exacerbation of a chronic interstitial lung disease (ILD), chronic pulmonary hypertension (PH) on PH-targeted...
- End-stage chronic cirrhosis with Child-Pugh Class C (Section 12.3)
- ICU admission for burn injury
- Current ICU stay \> 2 weeks or acute care hospital stay \> 4 weeks
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- San Franciso, California, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Lowell, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- The Bronx, New York, United States
- Durham, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
+ 8 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Little Rock, Arkansas, United States; La Jolla, California, United States; Los Angeles, California, United States; Palo Alto, California, United States; San Franciso, California, United States and 22 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.