Comparing precision ventilation to standard care for ARDS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study aims to compare a personalized lung-stress oriented ventilation strategy against standard mechanical ventilation in patients suffering from Acute Respiratory Distress Syndrome (ARDS). Participants will be randomly assigned to receive either precision ventilation, which is tailored to maintain lung stress within a physiological range, or guided usual care. The primary goal is to determine if this precise approach can improve survival rates at 60 days compared to standard care. Additionally, the study will evaluate the impact on lung injury and the safety profile of the ventilation strategies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years
2. Ventilator-dependent ARDS, with all of the following (a-e):

   1. Invasive ventilation with positive end-expiratory pressure (PEEP) ≥ 8 cm H2O or FiO2 ≥ 0.5
   2. 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 since last ABG: SpO2/FiO2 ≤ 316 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.
   3. Bilateral lung opacities on chest imaging not fully explained by effusions, lobar collapse, or nodules
   4. Respiratory failure not fully explained by heart failure or fluid overload
   5. Onset within 1 week of clinical insult or new/worsening symptoms
3. 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

Exclusion Criteria:

1. Esophageal manometry already in use clinically
2. 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)
3. Gross barotrauma or chest tube inserted to treat barotrauma (note: chest tube inserted strictly for drainage of pleural effusion is not an exclusion)
4. 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
5. Ongoing severe coagulopathy (platelet \< 5000/μL or INR \> 4)
6. Extracorporeal membrane oxygenation (ECMO) or CO2 removal (ECCO2R)
7. Neuromuscular disease that impairs spontaneous breathing (including but not limited to amyotrophic lateral sclerosis, Guillain-Barré syndrome, spinal cord injury at C5 or above)
8. 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 vasoactive medication, or lung transplant
9. End-stage chronic cirrhosis with Child-Pugh Class C (Section 12.3)
10. ICU admission for burn injury
11. Current ICU stay \> 2 weeks or acute care hospital stay \> 4 weeks
12. 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
13. 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.
14. Treating clinician refusal or unwilling to use protocol-specified ventilator settings/modes
15. Prisoner
16. Previous enrollment in this trial

Where it's running

• University of Arizona
  Tucson, Arizona, United States Recruiting
• University of Arkansas for Medical Sciences
  Little Rock, Arkansas, United States Recruiting
• University of California, San Diego
  La Jolla, California, United States Recruiting
• University of California, Los Angeles Medical Center
  Los Angeles, California, United States Recruiting
• Cedar-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• Stanford University
  Palo Alto, California, United States Recruiting

Study contacts

• Principal investigator: Daniel Talmor, MD MPH — Beth Israel Deaconess Medical Center
• Study coordinator: Valerie Goodspeed, MPH
• Email: vgoodspe@bidmc.harvad.edu
• Phone: 6176328055

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.