NCT05312385

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)

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 277 (actual)
• Sponsor: Sedana Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is 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 (ICU) adult patients.

Conditions

• Sedation

Interventions

Type	Name	Description
DRUG	Isoflurane	Inhaled isoflurane administered by Sedaconda ACD-S
DRUG	Propofol	Intravenous infusion of propofol
DRUG	Isoflurane (run-ins)	Inhaled isoflurane administered by Sedaconda ACD-S 3-5 run-in patients were enrolled at each site prior to randomization

Timeline

• Start date: 2022-04-28
• Primary completion: 2024-04-26
• Completion: 2024-10-24
• First posted: 2022-04-05
• Last updated: 2026-03-24
• Results posted: 2026-03-24

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study