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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 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.

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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.

Conditions Studied

Sedation

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

FieldValue
Enrollment Target 235 participants
Start Date 2022-04-28
Est. Completion 2024-10-30
Phase Phase 3

Sponsor

Sedana Medical

3 total trials

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What the Registry Record Tells You About NCT05312385

The ClinicalTrials.gov registry entry for NCT05312385 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 235 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 100,166-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 1 condition, with Sedation appearing as the primary indexed condition, and to 2 interventions - of which Propofol is the first listed.

NCT05312385 reports 14 study locations spanning 10 distinct geographic areas - top geographies include 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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.