At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 277 enrolled
Drug / intervention
Isoflurane +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Multicenter, Randomized, Controlled, Open Label, Assessor-Blinded Study to Evaluate the Efficacy and Safety of Inhaled Isoflurane Delivered Via the Sedaconda ACD-S Compared to Intravenous Propofol for Sedation of Mechanically Ventilated Intensive Care Unit Adult Patients (INSPiRE-ICU1)
In Brief
A Phase 3 clinical trial evaluating Isoflurane, Propofol, and 1 other intervention for Sedation. Completed, enrolled 277 participants across 14 sites.
Detailed Summary
This is a study to compare safety and efficacy of inhaled isoflurane administered via the Sedaconda ACD-S device system versus intravenous propofol for sedation of mechanically ventilated patients in the Intensive Care Unit (ICU) setting.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSedation
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2023202420252026
First PostedApr 2022
Enrollment StartApr 2022
Primary CompletionApr 2024
Study CompletionOct 2024
TodayJul 2026
First PostedApr 5, 2022
Enrollment StartApr 28, 2022
Primary CompletionApr 26, 2024
Study CompletionOct 24, 2024
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 4.2 years ago
Interventions
Isofluranedrug
Inhaled isoflurane administered by Sedaconda ACD-S
Propofoldrug
Intravenous infusion of propofol
Isoflurane (run-ins)drug
Inhaled isoflurane administered by Sedaconda ACD-S 3-5 run-in patients were enrolled at each site prior to randomization