A Pooled Analysis of Long-Term Outcomes After Inhaled Isoflurane Via the Sedaconda ACD-S Compared to Intravenous Propofol

This pooled analysis will assess Cognitive, Mental Health, Functioning, and Quality of Life Assessments data from the Phase 3 registration studies INSPiRE-ICU 1 (NCT05312385) and INSPiRE-ICU 2 (NCT05327296) to explore potential differences in Long-Term Outcomes at 3 and 6 months after treatment between critically ill mechanically ventilated patients sedated with inhaled isoflurane compared to sedated with intravenous propofol. The analyses were pre-planned and agreed prior to completion of enrollment of either study.

NCT Number	NCT06809218
Lead Sponsor	Sedana Medical Collaborators: Critical Illness, Brain Dysfunction, and Survivorship Center
Conditions	Post-Intensive Care Syndrome, Sedation
Enrollment	312 participants
Start Date	2022-04-22
Primary Completion	2024-11-14 (estimated)
Study Completion	2025-01-30 (estimated)
Updated on ClinicalTrials.gov	2025-02-05