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NCT06809218
A Pooled Analysis of Long-Term Outcomes After Inhaled Isoflurane Via the Sedaconda ACD-S Compared to Intravenous Propofol
Phase 3 trial testing Inhaled isoflurane administered by Sedaconda ACD-S in Post-Intensive Care Syndrome in 312 participants. Participants enrolled and being followed up; not accepting new ones.
14 November 2024
Quick facts
| Lead sponsor | Sedana Medical |
|---|---|
| Phase | Phase 3 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 312 |
| Start date | 22 April 2022 |
| Primary completion | 14 November 2024 |
| Estimated completion | 30 January 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Inhaled isoflurane administered by Sedaconda ACD-S — full drug profile →
- Intravenous infusion of propofol — full drug profile →
Conditions studied
- Post-Intensive Care Syndrome — all drugs for Post-Intensive Care Syndrome →
- Sedation — all drugs for Sedation →
Sponsor
Sedana Medical — full company profile →
Who can join
18 and older, any sex, with Post-Intensive Care Syndrome or Sedation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06809218
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other Sedana Medical trials
Trials by the same sponsor.
- NCT05327296 — Efficacy and Safety of Inhaled Isoflurane Delivered Via the Sedaconda ACD-S Compared to Intravenous Propofol for Sedatio · Phase 3 · completed
- NCT05312385 — Efficacy and Safety of Inhaled Isoflurane Delivered Via the Sedaconda ACD-S Compared to Intravenous Propofol for Sedatio · Phase 3 · completed
- NCT04684238 — Effect & Safety of Inhaled Isoflurane vs IV Midazolam for Sedation in Mechanically Ventilated Children 3-17 Years Old · Phase 3 · completed
- NCT07457593 — Expanded Access for Inhaled Isoflurane Delivered Via the Sedaconda ACD-S for Sedation of Difficult-to-Sedate Adult Mecha · available
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06809218 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sedana Medical
- Last refreshed: 5 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06809218.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing