CAVIARDS Trial

Uses

How it works

Dosage & preparation

Background

Highlighted claims

• CAVIARDS is a multicentre, open-label, phase III randomised controlled basket trial evaluating whether a physiology-based ventilation strategy improves outcomes in adults with moderate-to-severe ARDS. — Careful ventilation in acute respiratory distress syndrome: the protocol of the CAVIARDS international multicentre randomised basket trial
• The primary outcome is all-cause mortality within 60 days of randomisation. — Careful ventilation in acute respiratory distress syndrome: the protocol of the CAVIARDS international multicentre randomised basket trial
• The trial is being conducted in 33 intensive care units across eight countries: Argentina, Canada, Chile, France, Italy, Spain, the Netherlands, and the United States. — Careful ventilation in acute respiratory distress syndrome: the protocol of the CAVIARDS international multicentre randomised basket trial
• The target sample size is 740 patients total, with 370 patients in each of the two substudies. — Careful ventilation in acute respiratory distress syndrome: the protocol of the CAVIARDS international multicentre randomised basket trial
• The trial was originally designed for COVID-19 ARDS and was modified to a basket design on 8 November 2023 because of the major decrease in COVID-19 incidence. — Careful ventilation in acute respiratory distress syndrome: the protocol of the CAVIARDS international multicentre randomised basket trial
• Analyses follow the intention-to-treat principle, including all randomised patients regardless of protocol compliance. — Careful ventilation in acute respiratory distress syndrome: the protocol of the CAVIARDS international multicentre randomised basket trial
• The statistical analysis plan assumes the intervention can reduce day-60 mortality by an absolute 15%, powering the trial at 80%. — Careful ventilation in acute respiratory distress syndrome: the protocol of the CAVIARDS international multicentre randomised basket trial
• There is no futility stopping rule because early futility stopping could increase type II false-negative error. — Careful ventilation in acute respiratory distress syndrome: the protocol of the CAVIARDS international multicentre randomised basket trial