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COMPLETED 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)

NCT05327296 · View on ClinicalTrials.gov ↗

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

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05327296

The ClinicalTrials.gov registry entry for NCT05327296 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 282 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sedana Medical, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05327296 reports 16 study locations spanning 11 distinct geographic areas — top geographies include California, Massachusetts, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05327296?

The interventions under investigation include: Propofol (DRUG), Isoflurane (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05327296?

This trial is sponsored by Sedana Medical, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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