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Comparing precision ventilation to standard care for ARDS

PREcision VENTilation to Attenuate Ventilator-Induced Lung Injury: A Phase 3 Multicenter Randomized Clinical Trial

PHASE3 · Beth Israel Deaconess Medical Center · NCT06066502

This study tests if a personalized breathing method can help people with Acute Respiratory Distress Syndrome survive better than the usual care they receive.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment1100 (estimated)
Ages18 Years and up
SexAll
SponsorBeth Israel Deaconess Medical Center (other)
Locations24 sites (Tucson, Arizona and 23 other locations)
Trial IDNCT06066502 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with moderate to severe ARDS who are early in their course of treatment.

Not a fit: Patients with mild ARDS or those who do not require invasive ventilation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve survival rates for patients with ARDS.

How similar studies have performed: Previous studies have shown promise in improving outcomes with tailored ventilation strategies, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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 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 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 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 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
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: continuous home supplemental oxygen \> 3 liters/minute, pulmonary fibrosis, cystic fibrosis, lung transplant, or acute exacerbation of a chronic interstitial lung disease (ILD)
9. Severe shock: norepinephrine-equivalent dose ≥ 0.6 μg/kg/min or simultaneous receipt of ≥ 3 vasopressors
10. Severe liver disease, defined as Child-Pugh Class C (Section 12.3)
11. ICU admission for burn injury
12. Current ICU stay \> 2 weeks or acute care hospital stay \> 4 weeks
13. Estimated mortality \> 50% over 6 months due to underlying chronic medical condition (e.g. metastatic pancreatic cancer) as assessed by the study physician
14. 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
15. 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.
16. Treating clinician refusal or unwilling to use protocol-specified ventilator settings/modes
17. Prisoner
18. Previous enrollment in this trial

Where this trial is running

Tucson, Arizona and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Acute Respiratory Distress Syndrome, Respiratory Failure, critical care, critical illness, esophageal manometry, transpulmonary pressure, mechanical ventilation, lung stress

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.