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NCT05327296 · 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-ICU2)

A Phase 3 study of Sedation, sponsored by Sedana Medical.

Completed
Registry status
Phase 3
Development phase
282
Enrollment target
16
Study locations

NCT05327296 is a Phase 3 study of Sedation that has completed, run by Sedana Medical. The registered enrollment target is 282 participants, below the 100,162-participant average among 12 other Sedation trials with a reported enrollment target (100% lower). The trial reports 16 study locations across 11 states.

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The verdict

NCT05327296, a Phase 3 study of Sedation, has completed, sponsored by Sedana Medical.

COMPLETED
Registry status
Phase 3
Development phase
282 participants
Enrollment target
16
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

Interventions

  • DRUG Propofol
  • DRUG Isoflurane

Study Locations (16)

California

  • Memorial Health Services - Long Beach
  • University of California, Los Angeles - Los Angeles
  • Stanford University - Redwood City
  • University of California, San Diego - San Diego

Massachusetts

  • Massachusetts General Hospital - Boston
  • Beth Israel Deaconess Medical Center - Boston

Michigan

  • University of Michigan - Ann Arbor
  • Henry Ford Health System - Detroit

Florida

  • University of Miami - Coral Gables

Illinois

  • Rush University Medical Center - Chicago

New Jersey

  • The Cooper Health System - Camden

New York

  • The New York and Presbyterian Hospital - New York

Ohio

  • Ohio State University - Columbus

Trial Details

FieldValue
Enrollment Target 282 participants
Start Date 2022-06-30
Est. Completion 2024-11-14
Phase Phase 3

Sponsor

Sedana Medical

3 total trials

What the Registry Record Tells You About NCT05327296

The ClinicalTrials.gov registry entry for NCT05327296 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 282 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 100,162-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.

NCT05327296 reports 16 study locations spanning 11 distinct geographic areas - top geographies include California, Massachusetts, Michigan.

Frequently Asked Questions

What is clinical trial NCT05327296 about?

NCT05327296 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-ICU2)". 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 NCT05327296?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 282 participants. The study started on 2022-06-30. Estimated completion is 2024-11-14.

What conditions does trial NCT05327296 study?

This clinical trial studies the following conditions: Sedation.

What interventions are being tested in trial NCT05327296?

The interventions under investigation include: Propofol (DRUG), Isoflurane (DRUG).

Who is sponsoring clinical trial NCT05327296?

This trial is sponsored by Sedana Medical, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05327296 being conducted?

This trial has 16 study locations across California, Florida, Illinois, Massachusetts, Michigan. 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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