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Breathing in calm: new sedation method may keep ICU patients Clear-Headed

NCT ID NCT04341350

Prevention Sponsor: University Hospital, Brest 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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 study compares two ways to sedate ICU patients who need a breathing machine: inhaled sedation (using isoflurane gas) versus standard intravenous (IV) sedation. The goal is to see if the inhaled approach reduces the chance of delirium—a state of confusion that often occurs in the ICU. About 250 adults on ventilators for at least 24 hours will take part.

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

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2020

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Patient aged 18 and over * Patient requiring mechanical ventilation for at least 24 hours * The patient requires continuous and immediate sedation for more comfort, safety and to facilitate the administration of survival measures. * Consent obtained from patient or relative Exclusion Criteria: Patient hospitalized for the following reasons for admission: * Cardiac arrest * State of refractory epilepticus * Head trauma * Stroke * Hearing, visual or aphasia disorders before inclusion making it impossible to take the CAM-ICU * Sedation started more than 24 hours ago * Impairment of cognitive functions and / or dementia * Contraindication to halogenated gases (personal or family history of malignant hyperthermia, acute or chronic neuromuscular disease, hepatocellular insufficiency with PT \<30%) * Severe acute respiratory distress syndrome (ARDS) (Berlin criteria: PaO2 / FiO2 \<100 after ventilatory optimisation)) * PaCO2 at inclusion\> 50 mmHg after ventilatory optimisation * Patient for whom a procedure of "limitation of active therapies" is envisaged at inclusion * Patient under guardianship or curatorship * Minor patient * Pregnant or breastfeeding woman * Patient not affiliated to the social security scheme

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Conditions

The condition(s) this trial relates to.

delirium prevention target

As listed by the trial registrant

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

Prevention of delirium

Contacts and locations

Locations

  • CH Bourges

    Bourges, 18000, France

  • CH Corbeil Essonnes

    Corbeil-Essonnes, 91106, France

  • CH Le Mans

    Le Mans, 72039, France

  • CH Melun

    Melun, 77000, France

  • CH Morlaix

    Morlaix, 29672, France

  • CHU Montpellier

    Montpellier, 34295, France

  • CHU Poitiers

    Poitiers, 86021, France

  • CHU Rennes

    Rennes, 35033, France

  • CHU Tours

    Tours, 37044, France

  • CHU Tours - Réanimation Chirurgicale

    Tours, 37044, France

  • CHU de Brest

    Brest, 29200, France

  • GHBS Lorient

    Lorient, 56322, France