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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) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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, 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-ICU2)

NCT05327296•Sedana Medical

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+10 more criteria

Locations (16)

Memorial Health Services

Long Beach, California, United States

University of California, Los Angeles

Los Angeles, California, United States

Stanford University

Redwood City, California, United States

University of California, San Diego

San Diego, California, United States

University of Miami

Coral Gables, Florida, United States

Rush University Medical Center

Chicago, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Henry Ford Health System

Detroit, Michigan, United States

Key Dates

Start Date

June 30, 2022

Primary Completion Date

May 28, 2024

Completion Date

November 14, 2024

Last Updated

March 3, 2026

Enrollment

282

ACTUAL participants

Conditions

Sedation

Interventions

Isoflurane

DRUG

Propofol

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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)

Inclusion Criteria

Exclusion Criteria

Premedication in Children: a Clinical Trial Comparing Oral Ketamine and Oral Clonidine With Respect to Sedation Level and Opioid Consumption in Pediatrics Undergoing Elective Lower Abdominal Day-case Surgery.

Sedation During Endoscopy Using Remimazolam: Efficacy in a Novel Exploration

Inhaled Sedation in Critically Ill Patients

TEAS for Sedation During ERCP

qNOX Response to Nociceptive Motor Events During Procedural Sedation

Lullaby vs White Noise vs Silence in Pediatric MRI Sedation