Optimizing Ventilation for Patients with Acute Respiratory Distress Syndrome

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 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.

Why it matters

Who can join: the full rules

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 it's running

• New York University Grossman School of Medicine
  New York, New York, United States Recruiting
• Centro de Educación Médica e Investigaciones Clínicas Dr Norberto Quirno (CEMIC)
  Buenos Aires, Argentina Recruiting
• Complejo Médico Policía Federal Argentina Churruca Visca
  Buenos Aires, Argentina Recruiting
• Hospital Británico de Buenos Aires
  Buenos Aires, Argentina Recruiting
• Sanatorio Anchorena Recoleta
  Buenos Aires, Argentina Recruiting
• Sanatorio Mater Dei
  Buenos Aires, Argentina Recruiting

Study contacts

• Principal investigator: Laurent Brochard, MD — Unity Health Toronto
• Study coordinator: Laurent Brochard, MD
• Email: laurent.brochard@unityhealth.to
• Phone: 416-864-6060

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Gastric versus postpyloric feeding for adults with ARDS on prone ventilation

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• Using higher PEEP with mask noninvasive ventilation for people with pneumonia or ARDS

  This trial will test whether giving higher PEEP through a mask during noninvasive ventilation helps adults with pneumonia or ARDS avoid intubation and improve oxygenation.

  Recruiting Chongqing Medical University · Chongqing · NCT07298889

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.