Smart ventilator trial: can automation cut ICU breathing time?
NCT ID NCT04593810
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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1,201 people
The number who actually took part.
- Started
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Oct 2020
- Finished
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Sep 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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Academic Medical Center, Intensive Care
Amsterdam, Netherlands
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Canisius-Wilhelmina Hospital
Nijmegen, Netherlands
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Catharina Ziekenhuis
Eindhoven, Netherlands
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Diakonessenhuis, Utrecht
Utrecht, Netherlands
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Elisabeth-TweeSteden Ziekenhuis
Tilburg, Netherlands
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Flevoziekenhuis
Almere Stad, Netherlands
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Leiden UMC
Leiden, Netherlands
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Ospedale Policlinico San Martino
Genoa, Italy
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Policlinico San Matteo Fondazione IRCCS
Pavia, Italy
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Reinier de Graaf Gasthuis
Delft, Netherlands
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