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NCT05327296 · ClinicalTrials.gov registry record · Phase 3
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-ICU2)
A Phase 3 study of Sedation, sponsored by Sedana Medical.
- Completed
- Registry status
- Phase 3
- Development phase
- 282
- Enrollment target
- 16
- Study locations
NCT05327296: Completed Phase 3 study of Sedation, sponsored by Sedana Medical.
NCT05327296 is a Phase 3 study of Sedation that has completed, run by Sedana Medical. The registered enrollment target is 282 participants, below the 100,162-participant average among 12 other Sedation trials with a reported enrollment target (100% lower). The trial reports 16 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05327296, a Phase 3 study of Sedation, has completed, sponsored by Sedana Medical.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 282 participants
- Enrollment target
- 16
- Study locations
Study 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.
Primary Outcome
The Target Range is RASS -1 to -4. The Richmond Agitation-Sedation Scale (RASS) is used to measure the level of agitation or sedation in patients, particularly in critical care settings. It is a 10-point scale ranging from -5 to +4: +4 Combative - Violent, immediate danger to staff. +3 Very agitated - Pulls or removes tubes or catheters; aggressive. +2 Agitated - Frequent non-purposeful movement, fights ventilator. +1 Restless - Anxious but movements are not aggressive. 0 Alert and calm. -1 Dr
Conditions Studied
Interventions
- DRUG Propofol
- DRUG Isoflurane
Study Locations (16)
California
- Memorial Health Services - Long Beach
- University of California, Los Angeles - Los Angeles
- Stanford University - Redwood City
- University of California, San Diego - San Diego
Massachusetts
- Massachusetts General Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
Michigan
- University of Michigan - Ann Arbor
- Henry Ford Health System - Detroit
Florida
- University of Miami - Coral Gables
Illinois
- Rush University Medical Center - Chicago
New Jersey
- The Cooper Health System - Camden
New York
- The New York and Presbyterian Hospital - New York
Ohio
- Ohio State University - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 282 participants |
| Start Date | 2022-06-30 |
| Est. Completion | 2024-11-14 |
| Phase | Phase 3 |
What the finished NCT05327296 record still lists
NCT05327296 is an interventional study that assigns participants to a tested intervention. The registered 282 participants enrollment target is mid-sized for trials with a published cap, below the 100,162-participant average among 12 other Sedation trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Sedation appearing as the primary indexed condition, and to 2 interventions - of which Propofol is the first listed.
NCT05327296 lists 16 locations in 11 states (California, Massachusetts, Michigan).
Frequently Asked Questions
What is clinical trial NCT05327296 about?
NCT05327296 is a clinical study titled "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-ICU2)". 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.
What is the current status of trial NCT05327296?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 282 participants. The study started on 2022-06-30. Estimated completion is 2024-11-14.
What conditions does trial NCT05327296 study?
This clinical trial studies the following conditions: Sedation.
What interventions are being tested in trial NCT05327296?
The interventions under investigation include: Propofol (DRUG), Isoflurane (DRUG).
Who is sponsoring clinical trial NCT05327296?
This trial is sponsored by Sedana Medical, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05327296 being conducted?
This trial has 16 study locations across California, Florida, Illinois, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Sedation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05327296's enrollment target sits among peer trials
282 4th of 12 higher than 9 of 12 other Sedation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sedation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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Sedation During Endoscopy Using Remimazolam: Efficacy in a Novel Exploration
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A Pooled Analysis of Long-Term Outcomes After Inhaled Isoflurane Via the Sedaconda ACD-S Compared to Intravenous Propofol
ACTIVE NOT RECRUITING · Phase 3
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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)
ACTIVE NOT RECRUITING · Phase 3
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