Careful Ventilation in Acute Respiratory Distress Syndrome (COVID-19 and Non-COVID-19)
Recruiting now · Not applicable
Conditions studied: ARDS
In brief
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.).
Key facts
- Study ID
- NCT03963622
- Run by
- Unity Health Toronto
- People needed
- 740
- Starts
- 2020-11-23
- Expected to finish
- 2026-09-01
- Last updated by the study team
- 2026-01-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 y
- 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)
You may not qualify if…
- Received continuous mechanical ventilation > 7 days
- Known or clinically suspected elevated intracranial pressure (>18mmHg) necessitating strict control of PaCO2
- Known pregnancy
- Broncho-pleural fistula
- Severe liver disease (Child-Pugh Score ≥ 10)
- BMI >40kg/m2
- Anticipating withdrawal of life support and/or shift to palliation as the goal of care
- Patient is receiving ECMO at time of randomization
Where it is running
- New York University Grossman School of Medicine — New York, New York, United States (enrolling)
- Centro de Educación Médica e Investigaciones Clínicas Dr Norberto Quirno (CEMIC) — Buenos Aires, Argentina (enrolling)
- Complejo Médico Policía Federal Argentina Churruca Visca — Buenos Aires, Argentina (enrolling)
- Hospital Británico de Buenos Aires — Buenos Aires, Argentina (enrolling)
- Sanatorio Anchorena Recoleta — Buenos Aires, Argentina (enrolling)
- Sanatorio Mater Dei — Buenos Aires, Argentina (enrolling)
- Sanatorio Anchorena San Martín — San Martin, Argentina (enrolling)
- St. Michael's Hospital — Toronto, Canada (enrolling)
- Toronto General Hospital — Toronto, Canada (enrolling)
- Toronto Western Hospital — Toronto, Canada (enrolling)
- Pontificia Universidad Católica de Chile — Santiago, Chile (enrolling)
- CHU Amiens-Picardie — Amiens, France (enrolling)
- Centre hospitalier universitaire d'Angers — Angers, France (enrolling)
- CH Victor Dupouy — Argenteuil, France (enrolling)
- CH de Beauvais — Beauvais, France (enrolling)
- CHU Bordeaux - Haut Leveque — Bordeaux, France (enrolling)
- Hopital de la Cavale Blanche - CHRU Brest — Brest, France (enrolling)
- CH de Cholet — Cholet, France (enrolling)
- Hopital Intercommunal de Creteil — Créteil, France (enrolling)
- CHU Grenoble-Alpes — Grenoble, France (enrolling)
- Hopital Roger Salengro - CHU Lille — Lille, France (enrolling)
- Groupe Hospitalier de la Region de Mulhouse et Sud Alsace — Mulhouse, France (enrolling)
- Hopital de l'Archet 1 - CHU de Nice — Nice, France (enrolling)
- Hopital Europeen Georges-Pompidou — Paris, France (enrolling)
- CHU de Poitiers - La Miletrie — Poitiers, France (enrolling)
Full record on ClinicalTrials.gov
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