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NCT06809218 · ClinicalTrials.gov registry record · Phase 3
A Pooled Analysis of Long-Term Outcomes After Inhaled Isoflurane Via the Sedaconda ACD-S Compared to Intravenous Propofol
A Phase 3 study of Sedation and Post-Intensive Care Syndrome, sponsored by Sedana Medical.
- Active
- Registry status
- Phase 3
- Development phase
- 312
- Enrollment target
- 1
- Study location
NCT06809218: Active Phase 3 study of Sedation and Post-Intensive Care Syndrome, sponsored by Sedana Medical.
NCT06809218 is a Phase 3 study of Sedation and Post-Intensive Care Syndrome that is active but no longer recruiting, run by Sedana Medical. The registered enrollment target is 312 participants, below the 100,160-participant average among 12 other Sedation trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06809218, a Phase 3 study of Sedation and Post-Intensive Care Syndrome, is active but no longer recruiting, sponsored by Sedana Medical.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 312 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
A patient is classified as cognitive impaired if the patient has a score 2 SD (or more) worse than population mean for one test or has a score 1.5 SD (or more) worse than population mean in two or more of the following tests: TICS, WAIS IV Digit Span, Hayling Sentence Completion Test, Controlled Oral Word Association, WMS IV - Immediate Memory (Adult/Older Adult) and WMS IV - Delayed Memory (Adult/Older Adult), at 3 months post randomization. The analysis will take into account age, sex, level
Conditions Studied
Interventions
- DRUG Inhaled isoflurane administered by Sedaconda ACD-S
- DRUG Intravenous infusion of propofol
Study Locations (1)
Tennessee
- The Critical Illness, Brain Dysfunction and Survivorship (CIBS) Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 312 participants |
| Start Date | 2022-04-22 |
| Est. Completion | 2025-01-30 |
| Phase | Phase 3 |
What the registry record for NCT06809218 still lists
NCT06809218 is an interventional study that assigns participants to a tested intervention. The registered 312 participants enrollment target is mid-sized for trials with a published cap, below the 100,160-participant average among 12 other Sedation trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Sedation appearing as the primary indexed condition, and to 2 interventions - of which Inhaled isoflurane administered by Sedaconda ACD-S is the first listed.
NCT06809218 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT06809218 about?
NCT06809218 is a clinical study titled "A Pooled Analysis of Long-Term Outcomes After Inhaled Isoflurane Via the Sedaconda ACD-S Compared to Intravenous Propofol". 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 betw...
What is the current status of trial NCT06809218?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 312 participants. The study started on 2022-04-22. Estimated completion is 2025-01-30.
What conditions does trial NCT06809218 study?
This clinical trial studies the following conditions: Sedation, Post-Intensive Care Syndrome.
What interventions are being tested in trial NCT06809218?
The interventions under investigation include: Inhaled isoflurane administered by Sedaconda ACD-S (DRUG), Intravenous infusion of propofol (DRUG).
Who is sponsoring clinical trial NCT06809218?
This trial is sponsored by Sedana Medical, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06809218 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT06809218's enrollment target sits among peer trials
312 3rd of 12 higher than 10 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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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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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)
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