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New option for ICU patients who Won't settle with standard sedatives

NCT ID NCT07457593

What the study statuses mean

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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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This program offers inhaled isoflurane, given through a special device, to sedate adult ICU patients on breathing machines who are difficult to sedate with usual IV medicines. It aims to help patients who remain agitated or at risk of harming themselves despite standard treatments. The goal is to improve comfort and safety for these critically ill individuals.

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.

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

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; * Receiving invasive mechanical ventilation and continuous sedation in the ICU; * Inability to maintain a target sedation level ensuring patient comfort and safety with conventional intravenous sedatives, in clinically appropriate combinations and at maximum tolerated doses, despite optimized analgesia and ventilator settings, with 1. recurring episodes of agitation or self-harm, such as attempting or actual removal of an endotracheal tube or of indwelling catheters or monitors, or necessitating physical restraints; or 2. escalating sedative and opioid drug doses, despite mitigating strategies (e.g., sedative drug combinations or rotation to reduce toxicity); or 3. clinical concerns for, or indications of, serious untoward effects of ongoing conventional intravenous sedation and analgesia agents (e.g., hypertriglyceridemia, propofol-related infusion syndrome, bradycardia, iatrogenic withdrawal syndrome); and * No other available sedative option is considered appropriate * Is not currently enrolled in or is eligible for a clinical study that would prohibit the participation in this EAP. Exclusion Criteria: * Ventilator tidal volume \<200 or \>1000 mL * Need for high frequency oscillation ventilation (HFOV) or high frequency percussive ventilation (HFPV) * Comfort care only (end of life care); * Suspected but unmonitored elevated intracranial pressure (e.g., patients with acute stroke, severe head trauma, meningitis without ICP monitoring); * Contraindication to isoflurane, including: 1. Known or suspected personal or family history of malignant hyperthermia (MH) or high risk for MH or acute drug-induced muscle injury (eg, muscular dystrophies); 2. Severe hemodynamic compromise; 3. Known hypersensitivity reaction to isoflurane or other halogenated volatile anesthetic agents * History of ventricular tachycardia/Long QT Syndrome; * Female patients who are pregnant or breast-feeding; * Imperative need for continuous active humidification through mechanical ventilation circuit; * Any medical conditions, that, in the Investigator´s opinion, would impose excessive risk to the patient or would adversely affect the patient's participation in the EAP; * Inability to obtain informed consent.

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