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NCT05312385 · 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-ICU1)
A Phase 3 study of Sedation, sponsored by Sedana Medical.
- Active
- Registry status
- Phase 3
- Development phase
- 235
- Enrollment target
- 14
- Study locations
NCT05312385: Active Phase 3 study of Sedation, sponsored by Sedana Medical.
NCT05312385 is a Phase 3 study of Sedation that is active but no longer recruiting, run by Sedana Medical. The registered enrollment target is 235 participants, below the 100,166-participant average among 12 other Sedation trials with a reported enrollment target (100% lower). The trial reports 14 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05312385, a Phase 3 study of Sedation, is active but no longer recruiting, sponsored by Sedana Medical.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 235 participants
- Enrollment target
- 14
- 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 (14)
Texas
- University of Texas Southwestern Medical Center - Dallas
- Houston Methodist Hospital - Houston
- MD Anderson Cancer Center - Houston
Massachusetts
- Tufts Medical Center - Boston
- The Brigham and Women´s Hospital - Boston
Ohio
- University of Cincinnati - Cincinnati
- The Cleveland Clinic Foundation - Cleveland
Colorado
- University of Colorado Anschutz Medical Campus - Aurora
Georgia
- Emory University - Atlanta
Illinois
- University of Chicago - Chicago
Minnesota
- Mayo Clinic - Rochester
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 235 participants |
| Start Date | 2022-04-28 |
| Est. Completion | 2024-10-30 |
| Phase | Phase 3 |
What the registry record for NCT05312385 still lists
NCT05312385 is an interventional study that assigns participants to a tested intervention. The registered 235 participants enrollment target is mid-sized for trials with a published cap, below the 100,166-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.
NCT05312385 lists 14 locations in 10 states (Texas, Massachusetts, Ohio).
Frequently Asked Questions
What is clinical trial NCT05312385 about?
NCT05312385 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-ICU1)". 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 NCT05312385?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 235 participants. The study started on 2022-04-28. Estimated completion is 2024-10-30.
What conditions does trial NCT05312385 study?
This clinical trial studies the following conditions: Sedation.
What interventions are being tested in trial NCT05312385?
The interventions under investigation include: Propofol (DRUG), Isoflurane (DRUG).
Who is sponsoring clinical trial NCT05312385?
This trial is sponsored by Sedana Medical, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05312385 being conducted?
This trial has 14 study locations across Colorado, Georgia, Illinois, Massachusetts, Minnesota. 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 NCT05312385's enrollment target sits among peer trials
235 6th of 12 higher than 7 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
-
Sedation During Endoscopy Using Remimazolam: Efficacy in a Novel Exploration
RECRUITING · Phase 3
-
A Pooled Analysis of Long-Term Outcomes After Inhaled Isoflurane Via the Sedaconda ACD-S Compared to Intravenous Propofol
ACTIVE NOT RECRUITING · 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)
COMPLETED · Phase 3
-
Oral vs IV Sedation for Cataract Surgery in Older Adults
RECRUITING · Phase 4
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RECRUITING · NA
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The Million Anesthesia Cases Study (MACS) - a Cohort Study of Preoperative Fasting and Perioperative Outcomes
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