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) (INSPiRE-ICU1)

March 3, 2026 updated by: Sedana Medical

A Phase 3, Multicenter, Randomized, Controlled, Open Label, Assessor-Blinded Study to Evaluate the 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a phase 3, multicenter, randomized, controlled, open-label, assessor-blinded study to evaluate the efficacy and safety of inhaled isoflurane delivered via the Sedaconda ACD-S compared to intravenous propofol for sedation of mechanically ventilated Intensive Care Unit (ICU) adult patients.

Study Type

Interventional

Enrollment (Actual)

277

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
      • Boston, Massachusetts, United States, 02115
        • The Brigham and Women´s Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84111
        • Intermountain Health Care Health Services
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults ≥18 years of age;
  • Patients who are anticipated to require >12 hours of invasive mechanical ventilation and continuous sedation in the ICU; and
  • Receipt of continuous sedation due to clinical need for sedation to RASS <0.

Exclusion Criteria:

  • Need for RASS -5;
  • Sedation for invasive mechanical ventilation immediately prior to Baseline for >72 hours;
  • Severe neurological condition before ICU admission that causes the patient to lack ability to participate in the study (ie, unable to be assessed for RASS and CPOT);
  • Ventilator tidal volume <200 or >1000 mL at Baseline;
  • Need for extracorporeal membrane oxygenation (ECMO), extracorporeal CO2 removal (ECCO2R), high frequency oscillation ventilation (HFOV), or high frequency percussive ventilation (HFPV) at Screening;
  • Comfort care only (end of life care);
  • Contraindication to propofol or isoflurane;
  • Known or family history of MH;
  • Severe hemodynamic compromise, defined as the need for norepinephrine ≥0.3 mcg/kg/min (or equivalent vasopressor dose) to maintain blood pressure within acceptable range, assumed to be mean arterial pressure ≥65 mmHg unless prescribed clinically;
  • Allergy to isoflurane or propofol, or have propofol infusion syndrome.
  • History of ventricular tachycardia/Long QT Syndrome;
  • Requirement of IV benzodiazepine or barbiturate administration for seizures or dependencies, including alcohol withdrawal
  • Neuromuscular disease that impairs spontaneous ventilation (eg, C5 or higher spinal cord injury, amyotrophic lateral sclerosis, etc);
  • Concurrent enrollment in another study that, in the Investigator's opinion, would impact the patient's safety or assessments of this study;
  • Participation in other study involving investigational drug(s) or devices(s) within 30 days prior to Randomization;
  • Anticipated requirement of treatment with continuous infusion of a neuromuscular blocking agent for >4 hours;
  • Female patients who are pregnant or breast-feeding;
  • Imperative need for continuous active humidification through mechanical ventilation circuit;
  • Attending physician's refusal to include the patient; or
  • Inability to obtain informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Isoflurane
Inhaled isoflurane administered via Sedaconda ACD-S
Drug: Isoflurane
Inhaled isoflurane administered by Sedaconda ACD-S
Drug: Isoflurane (run-ins)
Inhaled isoflurane administered by Sedaconda ACD-S 3-5 run-in patients were enrolled at each site prior to randomization
Active Comparator: Propofol
Propofol administered as intravenous infusion
Drug: Propofol
Intravenous infusion of propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Percentage of Time Sedation Depth is Maintained Within the Target Range, in Absence of Rescue Sedation, as Assessed According to the RASS Scale, in Isoflurane- vs Propofol-treated Patients
Time Frame: From start to end of study treatment (up to 48 (±6) hours)

The Target Range is RASS -1 to -4.

The Richmond Agitation-Sedation Scale (RASS) is used to measure the level of agitation or sedation in patients, particularly in critical care settings. It is a 10-point scale ranging from -5 to +4:

+4 Combative - Violent, immediate danger to staff. +3 Very agitated - Pulls or removes tubes or catheters; aggressive. +2 Agitated - Frequent non-purposeful movement, fights ventilator. +1 Restless - Anxious but movements are not aggressive. 0 Alert and calm. -1 Drowsy - Not fully alert, but has sustained awakening (eye-opening/eye contact) to voice for more than 10 seconds. -2 Light sedation - Briefly awakens with eye contact to voice for less than 10 seconds. -3 Moderate sedation - Movement or eye opening to voice, but no eye contact. -4 Deep sedation - No response to voice, but movement or eye opening to physical stimulation. -5 Unarousable - No response to voice or physical stimulation.
From start to end of study treatment (up to 48 (±6) hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Key Secondary: The Effect of Isoflurane vs Propofol on the Wake up Time at End of Study Drug Treatment
Time Frame: Up to 4 hours after stop of study drug treatment (up to 54 (±6) hours)
Up to 4 hours after stop of study drug treatment (up to 54 (±6) hours)
Key Secondary: The Effect of Isoflurane vs Propofol on Spontaneous Breathing Effort During the Study Drug Treatment Period
Time Frame: From start to end of study treatment, up to 48 (±6) hours
Proportion of ventilator parameter observations with spontaneous breathing efforts during the study drug treatment period
From start to end of study treatment, up to 48 (±6) hours
Other Secondary: The Effect of Isoflurane vs Propofol on Days Alive and Free of Mechanical Ventilation Through Study Day 30
Time Frame: From start of study treatment up to 30 days
From start of study treatment up to 30 days
Other Secondary: The Effect of Isoflurane vs Propofol on Delirium and Coma Free Days Until 7 Days After End of Study Treatment
Time Frame: From start of study treatment until 7 days after end of treatment (up to 9 days post study drug treatment initiation)
From start of study treatment until 7 days after end of treatment (up to 9 days post study drug treatment initiation)
Other Secondary: The Effect of Isoflurane vs Propofol on Mortality at 30 Days After Randomization
Time Frame: At 30 days after randomization
Participants reported represent participants that died between randomization and 30 days in the Safety population
At 30 days after randomization
Other Secondary: The Effect of Isoflurane vs Propofol on Mortality at 3 Months After Randomization
Time Frame: At 3 months after randomization
Participants reported represent participants that died between randomization and 3 months in the Safety population
At 3 months after randomization
Other Secondary: The Effect of Isoflurane vs Propofol on Mortality at 6 Months After Randomization
Time Frame: At 6 months after randomization
Participants reported represent participants that died between randomization and 6 months in the Safety population
At 6 months after randomization
Other Secondary: Sedaconda ACD-S Device Deficiencies in Patients Receiving Isoflurane
Time Frame: From start to end of study treatment (up to 48 (±6) hours)
From start to end of study treatment (up to 48 (±6) hours)
Other Secondary: The Use of Restraints in Patients Receiving Isoflurane vs Propofol
Time Frame: From start to end of study treatment (up to 48 (±6) hours)
Incidence of restraints measured twice daily
From start to end of study treatment (up to 48 (±6) hours)
Key Secondary: The Effect of Isoflurane vs Propofol on Use of Opioids During the Study Treatment Period
Time Frame: From 60 minutes prior to Baseline until end of study treatment (60 minutes + up to 48 (±6) hours)
To compare the effect of isoflurane vs propofol on use of opioids during the study treatment period by measuring change in mean fentanyl-equivalent opioid dose during the study treatment period compared to mean opioid dose during the 60 minutes prior to baseline
From 60 minutes prior to Baseline until end of study treatment (60 minutes + up to 48 (±6) hours)
Key Secondary: The Effect of Isoflurane vs Propofol on Cognitive Recovery After End of Study Drug Treatment
Time Frame: At 60 minutes (±10 minutes) after end of study drug treatment (up to 49 (±6) hours)
Cognitive recovery will be assessed by the 7-point scale of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU-7) at 60 (±10) minutes after end of study drug treatment in patients not re-sedated with benzodiazepine or propofol infusions. The scale ranges from 0 to 7, with higher scores indicating more severe delirium.
At 60 minutes (±10 minutes) after end of study drug treatment (up to 49 (±6) hours)
Other Secondary: The Effect of Isoflurane vs Propofol on Time From Sedation Termination to Extubation in Patients for Whom Study Drug is Terminated for Extubation
Time Frame: From end of study treatment sedation to extubation (up to 7 Days after randomization)
To compare the effect of isoflurane vs propofol on time from sedation termination to extubation in patients for whom study drug is terminated for extubation
From end of study treatment sedation to extubation (up to 7 Days after randomization)
Other Secondary: The Effect of Isoflurane vs Propofol on Days Alive and Free of the ICU
Time Frame: From start of study treatment up to 30 days
From start of study treatment up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sedana Medical

Investigators

  • Principal Investigator: Kimberly Rengel, M.D., Vanderbilt University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2022

Primary Completion (Actual)

April 26, 2024

Study Completion (Actual)

October 24, 2024

Study Registration Dates

First Submitted

March 11, 2022

First Submitted That Met QC Criteria

March 28, 2022

First Posted (Actual)

April 5, 2022

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SED003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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