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Smart ventilator trial: can automation cut ICU breathing time?

NCT ID NCT04593810

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tested a fully automated ventilator mode (INTELLiVENT-ASV) against standard ventilation in 1,201 ICU patients who needed a breathing tube. The goal was to see if the smart system could shorten the time patients needed the ventilator and improve breathing quality. Results will show whether automation offers benefits over conventional care.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

1,201 people

The number who actually took part.

Started

Oct 2020

Finished

Sep 2025

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: * admission to one of the participating ICUs * intubated and receiving invasive ventilation * anticipated duration of ventilation of at least 24 hours Exclusion Criteria: * age below 18 years * patients with suspected or confirmed pregnancy * invasive ventilation \> 1 hour in the ICU * invasive ventilation \> 6 hours directly preceding the current ICU admission * participation in another interventional trial using similar endpoints * after recent pneumectomy or lobectomy * morbid obesity (body mass index \> 40 kg/m2) * premorbid restrictive pulmonary disease * unreliable pulse oximetry (secondary to carbon monoxide poisoning or sickle cell disease) * any neurologic diagnosis that can prolong duration of mechanical ventilation, e.g., Guillain-Barré syndrome, high spinal cord lesion or amyotrophic lateral sclerosis, multiple sclerosis, or myasthenia gravis * patients receiving or planned to receive veno-venous, veno-arterial or arterio-venous extracorporeal membrane oxygenation (ECMO) * unavailability of INTELLiVENT-ASV (no ventilator available with this ventilation mode) * previously randomized in this study * no informed consent

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As listed by the trial registrant

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

Contacts and locations

Locations

  • Academic Medical Center, Intensive Care

    Amsterdam, Netherlands

  • Canisius-Wilhelmina Hospital

    Nijmegen, Netherlands

  • Catharina Ziekenhuis

    Eindhoven, Netherlands

  • Diakonessenhuis, Utrecht

    Utrecht, Netherlands

  • Elisabeth-TweeSteden Ziekenhuis

    Tilburg, Netherlands

  • Flevoziekenhuis

    Almere Stad, Netherlands

  • Leiden UMC

    Leiden, Netherlands

  • Ospedale Policlinico San Martino

    Genoa, Italy

  • Policlinico San Matteo Fondazione IRCCS

    Pavia, Italy

  • Reinier de Graaf Gasthuis

    Delft, Netherlands

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