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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 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.

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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.

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

FieldValue
Enrollment Target 312 participants
Start Date 2022-04-22
Est. Completion 2025-01-30
Phase Phase 3

Sponsor

Sedana Medical

3 total trials

What the Registry Record Tells You About NCT06809218

The ClinicalTrials.gov registry entry for NCT06809218 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 312 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 100,160-participant average among 12 other Sedation trials with a reported enrollment target (100% lower). The listed sponsor is Sedana Medical, which has 3 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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