Careful Ventilation in Acute Respiratory Distress Syndrome (COVID-19 and Non-COVID-19)
ConditionARDS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUnity Health Toronto
About this trial
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
Qualifiers
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)
Disqualifiers
Received continuous mechanical ventilation > 7 days
Known or clinically suspected elevated intracranial pressure (>18mmHg) necessitating strict control of PaCO2
Known pregnancy
Broncho-pleural fistula
Trial design
Treatments tested in this trial
- Respiratory Mechanics
- Standard Ventilation Strategy
Treatment groups
740 Participants
are divided into 2 treatment groupsSponsors and collaborators
Unity Health Toronto
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
University of Toronto
Collaborator
Applied Health Research Centre
Collaborator
Source ClinicalTrials.gov