NCT03963622 Careful Ventilation in Acute Respiratory Distress Syndrome (COVID-19 and Non-COVID-19)
| NCT ID | NCT03963622 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Unity Health Toronto |
| Condition | ARDS |
| Study Type | INTERVENTIONAL |
| Enrollment | 740 participants |
| Start Date | 2020-11-23 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 740 participants in total. It began in 2020-11-23 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.).
Eligibility 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
Contact & Investigator
Laurent Brochard, MD
PRINCIPAL INVESTIGATOR
Unity Health Toronto
Frequently Asked Questions
Who can join the NCT03963622 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying ARDS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03963622 currently recruiting?
Yes, NCT03963622 is actively recruiting participants. Contact the research team at laurent.brochard@unityhealth.to for enrollment information.
Where is the NCT03963622 trial being conducted?
This trial is being conducted at New York, United States, Buenos Aires, Argentina, Buenos Aires, Argentina, Buenos Aires, Argentina and 11 additional locations.
Who is sponsoring the NCT03963622 clinical trial?
NCT03963622 is sponsored by Unity Health Toronto. The principal investigator is Laurent Brochard, MD at Unity Health Toronto. The trial plans to enroll 740 participants.