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Optimizing Ventilation for Patients with Acute Respiratory Distress Syndrome

Careful Ventilation in Acute Respiratory Distress Syndrome

NA · Unity Health Toronto · NCT03963622

This study tests a new way of using ventilators to see if it can help patients with acute respiratory distress syndrome, including those with COVID-19, live longer and breathe better.

Quick facts

PhaseNA
Study typeInterventional
Enrollment740 (estimated)
Ages18 Years and up
SexAll
SponsorUnity Health Toronto (other)
Locations33 sites (New York, New York and 32 other locations)
Trial IDNCT03963622 on ClinicalTrials.gov

What this trial studies

This multicenter randomized controlled trial evaluates the effectiveness of a ventilator management strategy based on respiratory mechanics to reduce mortality in patients with acute respiratory distress syndrome (ARDS). The study includes both COVID-19 and non-COVID-19 patients, utilizing a basket trial design to implement a standardized mechanical ventilation protocol across different populations. By assessing the recruitability and effort of patients, the trial aims to improve ventilation outcomes and minimize ventilator-induced lung injury. The trial's adaptive design allows for modifications based on interim results to enhance patient care.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with moderate to severe ARDS within 48 hours of meeting Berlin ARDS criteria.

Not a fit: Patients who have been on continuous mechanical ventilation for more than 7 days or have severe comorbid conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly lower mortality rates in ARDS patients by improving ventilation strategies.

How similar studies have performed: Other studies have shown promise in optimizing mechanical ventilation strategies for ARDS, suggesting potential for success in this novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Age ≥ 18 y
2. Moderate or severe ARDS (PaO2/FiO2 ≤ 200 mmHg) within 48 h of meeting Berlin ARDS criteria (Patients who were eligible at the time of screening and whose PaO2/FiO2 became \> 200 mm Hg under prone positioning when starting the protocol remained eligible)

Exclusion Criteria:

1. Received continuous mechanical ventilation \> 7 days
2. Known or clinically suspected elevated intracranial pressure (\>18mmHg) necessitating strict control of PaCO2
3. Known pregnancy
4. Broncho-pleural fistula
5. Severe liver disease (Child-Pugh Score ≥ 10)
6. BMI \>40kg/m2
7. Anticipating withdrawal of life support and/or shift to palliation as the goal of care
8. Patient is receiving ECMO at time of randomization

Where this trial is running

New York, New York and 32 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: ARDS, Ventilation, Airway closure, Lung recruitment, COVID-19, Basket trial

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.