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

Careful Ventilation in Acute Respiratory Distress Syndrome

Who can join

Ages 18 and older · All sexes

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

About the study

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.).

What is being tested

• Respiratory Mechanics (other)
• Standard Ventilation Strategy (other)

Sponsor: Unity Health Toronto · Participants: 740 · Started: Nov 23, 2020

Contact the study team

• Laurent Brochard, MD · Phone: 416-864-6060

Official record on ClinicalTrials.gov — NCT03963622

Locations in the U.S.

Conditions

• Post-COVID Conditions (Long COVID)

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.