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A Pooled Analysis of Long-Term Outcomes After Inhaled Isoflurane Via the Sedaconda ACD-S Compared to Intravenous Propofol
Sponsor: Sedana Medical
Summary
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.
Official title: INSPiRE-ICU 1 & 2: A Pooled Analysis of Long-Term Outcomes at 3 and 6 Months After Inhaled Isoflurane Delivered Via the Sedaconda ACD-S Compared to Intravenous Propofol for Sedation of Mechanically Ventilated Intensive Care Unit Adult Patients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
312
Start Date
2022-04-22
Completion Date
2025-01-30
Last Updated
2025-02-05
Healthy Volunteers
No
Conditions
Interventions
Inhaled isoflurane administered by Sedaconda ACD-S
Intervention: isoflurane
Intravenous infusion of propofol
Intervention: propofol
Locations (1)
The Critical Illness, Brain Dysfunction and Survivorship (CIBS) Center
Nashville, Tennessee, United States