Effect of Dexmedetomidine Compared to Placebo on Reducing Non-Invasive Ventilation Failure in Adults with Acute Respiratory Failure

What this Trial Is About

Acute respiratory failure ARF is a common reason for intensive care admission, and non-invasive ventilation NIV is a life-saving treatment option that is safer and less invasive than invasive mechanical ventilation IMV. This trial evaluates dexmedetomidine, a sedative that promotes wakefulness and reduces delirium without affecting breathing, compared to a placebo. The study aims to see if dexmedetomidine reduces NIV failure in adults with ARF who experience agitation or intolerance to NIV. Participants will be randomly assigned to receive either dexmedetomidine or a placebo infusion. The dexmedetomidine dose starts at 0.5 mcgkghour and is adjusted every 20-30 minutes to maintain light sedation without a loading dose. The placebo contains only saline and is identical in appearance. This trial is blinded and conducted across multiple international centers, comparing the effects of dexmedetomidine versus placebo on NIV tolerance. During the study, participants will be closely monitored for NIV failure, defined as the need for intubation or death within 28 days. Other assessments include delirium, agitation, intubation rates by 14 days, and mortality at ICU and hospital discharge. The trial involves intensive monitoring in ICU or equivalent settings, with safety and outcome data collected throughout. Participants remain in the study until 28 to 90 days post-treatment for outcome evaluation.

Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults