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Careful Ventilation in Acute Respiratory Distress Syndrome (COVID-19 and Non-COVID-19)

RecruitingNAAges 18 Years - anyAllUnity Health Toronto
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In plain words

What the trial is, and whether it could suit you

This is a multicenter randomized controlled clinical trial with an adaptive design assessing the efficacy of setting the ventilator based on measurements of respiratory mechanics (recruitability and effort) to reduce Day 60 mortality in patients with acute respiratory distress syndrome (ARDS). The CAVIARDS study is also a basket trial; a basket trial design examines a single intervention in multiple disease populations. CAVIARDS consists of an identical 2-arm mechanical ventilation protocol implemented in two different study populations (COVID-19 and non-COVID-19 patients). As per a typical basket trial design, the operational structure of both the COVID-19 substudy (CAVIARDS-19) and non-COVID-19 substudy (CAVIARDS-all) is shared (recruitment, procedures, data collection, analysis, management, etc.).

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Respiratory Mechanics
  • Standard Ventilation Strategy
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Where

33 sites
New York University Grossman School of Medicine
New York, United States
Centro de Educación Médica e Investigaciones Clínicas Dr Norberto Quirno (CEMIC)
Buenos Aires, Argentina
Complejo Médico Policía Federal Argentina Churruca Visca
Buenos Aires, Argentina
Hospital Británico de Buenos Aires
Buenos Aires, Argentina
Sanatorio Anchorena Recoleta
Buenos Aires, Argentina
Sanatorio Mater Dei
Buenos Aires, Argentina
Sanatorio Anchorena San Martín
San Martin, Argentina
St. Michael's Hospital
Toronto, Canada

…and 25 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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