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New inhaled sedative could change ICU care

NCT ID NCT05327296

Symptom relief Sponsor: Sedana Medical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested whether an inhaled anesthetic gas, isoflurane, given through a special device (Sedaconda ACD-S), works as well as the standard IV drug propofol for keeping ICU patients calm while on a breathing machine. The trial included 282 adults expected to need sedation for over 12 hours. Researchers measured how often sedation stayed in the target range and whether opioid use could be reduced.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
isoflurane (inhaled anesthetic gas)
What this could lead to
If it works, this could offer a new sedation option for ICU patients on ventilators, potentially reducing opioid use.
What could go wrong
This is a completed phase 3 trial, but results may not show a clear advantage over propofol. Risks include side effects like low blood pressure or breathing issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

282 people

The number who actually took part.

Started

Jun 2022

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sedation

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Memorial Health Services

    Long Beach, California, 90807, United States

  • Memorial Hermann Health Services

    Houston, Texas, 77030, United States

  • Ohio State University

    Columbus, Ohio, 43210, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Stanford University

    Redwood City, California, 94063, United States

  • The Cooper Health System

    Camden, New Jersey, 08103, United States

  • The New York and Presbyterian Hospital

    New York, New York, 10032, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • University of California, Los Angeles

    Los Angeles, California, 90095, United States

  • University of California, San Diego

    San Diego, California, 92023, United States

  • University of Miami

    Coral Gables, Florida, 33146, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23284, United States

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