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Breathing in sedation: could a gas help ICU patients leave the ventilator faster?

NCT ID NCT07000526

Symptom relief Sponsor: Instituto de Investigación Hospital Universitario La Paz Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 30, 2026 · Updated 2 times

Summary

This study tests whether giving sedation as a gas (isoflurane) instead of through an IV (propofol) helps critically ill patients on breathing machines recover faster. About 620 adults in the ICU who need deep sedation will be randomly assigned to one of the two methods. The main goal is to see how many days they are alive and off the ventilator within the first 28 days.

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) and Propofol (intravenous)
What this could lead to
If it works, this could show that inhaled sedation helps patients come off ventilators faster and spend less time in the ICU.
What could go wrong
This is a phase 4 trial, but it's still early to know if inhaled sedation is truly better. Results may not apply to all ICU patients, and there are risks like breathing problems or heart 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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 620 people

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

Started

Dec 2025

Expected to finish

Dec 2027

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 to 80 years

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: \- Adult patients receiving mechanical ventilation, with an anticipated duration \>48 hours after randomization, and requiring deep sedation (target RASS between -3 and -5). Exclusion Criteria: * Contraindication to isoflurane or propofol * Patients with maternal ancestry from Venezuela, due to the potential presence of an mt-ND4 gene mutation associated with neurological injury after exposure to certain volatile anaesthetic agents * Significant air leak, defined as a leak exceeding 30% of the delivered minute ventilation * Allergy to isoflurane or propofol * Cardiopulmonary arrest * History of ventricular tachycardia or long QT syndrome * Tidal volume \< 300 mL or PaCO₂ \> 50 mmHg at the time of randomization. * Invasive mechanical ventilation for more than 48 hours at the time of randomization. * Pregnancy * Breast feeding * Acute neurological condition * Patients expected to require repeated surgical interventions during their ICU stay. * ECMO * ECCO2R * Active humidification strictly required * Neuromuscular disease or high spinal cord injury likely to prevent discontinuation of mechanical ventilation due to baseline condition * Requirement for benzodiazepine use for a specific indication * Burns * Life expectancy less than 48 hours, or patients with such a level of severity that death during the ICU stay is considered highly likely. * Any condition (e.g., blindness, deafness, dementia) or language barrier that prevents the administration of delirium or cognitive assessment scales. * Lack of informed consent

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Conditions

The condition(s) this trial relates to.

delirium

As listed by the trial registrant

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

Airway extubation Sedation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    22 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Arnau de Vilanova

    NOT_YET_RECRUITING

    Lleida, Spain

  • Hospital Clínico Universitario de Valencia

    RECRUITING

    Valencia, Spain

  • Hospital Galdakao-Usansolo Ospitalea

    NOT_YET_RECRUITING

    Galdakao, Vizcaya, Spain

  • Hospital Germans Trias i Pujol

    RECRUITING

    Badalona, Spain

  • Hospital Regional Universitario de Málaga

    NOT_YET_RECRUITING

    Málaga, Spain

  • Hospital Univeritario Puerta de Hierro

    NOT_YET_RECRUITING

    Madrid, Spain

  • Hospital Universitario Doctor José Molina Orosa

    NOT_YET_RECRUITING

    Arrecife, Lanzarote-Canary Islands, 35500, Spain

  • Hospital Universitario Gregorio Marañon

    RECRUITING

    Madrid, Spain

  • Hospital Universitario Infanta Leonor

    RECRUITING

    Madrid, Spain

  • Hospital Universitario Joan XXIII

    RECRUITING

    Tarragona, Spain

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, 28029, Spain

  • Hospital Universitario Ramon y Cajal

    NOT_YET_RECRUITING

    Madrid, 28029, Spain

  • Hospital Universitario Rey Juan Carlos

    RECRUITING

    Madrid, Spain

  • Hospital Universitario Rio Hortega

    RECRUITING

    Valladolid, Spain

  • Hospital Universitario Valle de Hebron

    RECRUITING

    Barcelona, Spain

  • Hospital Universitario de Albacete

    NOT_YET_RECRUITING

    Albacete, Spain

  • Hospital Universitario de Bellvitge

    RECRUITING

    Barcelona, Spain

  • Hospital Universitario de Fuenlabrada

    NOT_YET_RECRUITING

    Madrid, 28029, Spain

  • Hospital Universitario de Jaen

    NOT_YET_RECRUITING

    Jaén, Spain

  • Hospital Universitario de Toledo

    NOT_YET_RECRUITING

    Toledo, Spain

  • Hospital Universitario de la Princesa

    RECRUITING

    Madrid, Spain

  • Hospital Vega Baja

    RECRUITING

    Orihuela, Alicante, Spain

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