Smart lung support for adults on a ventilator in the ICU

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter observational effort runs the IntelliLung artificial-intelligence decision support software in parallel with routine care for adults on invasive mechanical ventilation, including patients with and without ARDS and those receiving extracorporeal lung support. The system generates ventilator-setting recommendations while clinicians retain final decision-making authority; researchers will record the clinician-selected settings and the AI recommendations. The main analysis quantifies concordance between clinician settings and IntelliLung recommendations and explores factors associated with agreement or disagreement. Data are collected across participating centers in Germany, Italy, and Poland to describe real-world performance and acceptability.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male and female patients, age ⪰18 years
2. Written informed consent
3. Invasively mechanically ventilated patients expected to be intubated for more than 24 hours.

Exclusion Criteria:

1. Expected to die within ≤48 hours
2. Participation in an interventional mechanical ventilation trial
3. Mechanical Ventilation with a closed-loop ventilation mode
4. Persons dependent on the sponsor and/or investigator
5. Subjects who are currently imprisoned or otherwise in confinement ordered by law or other official authorities

Where it's running

• Department of Anesthesiology and Intensive Care Medicine, Pulmonary Engineering Group, Faculty of Medicine and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany
  Dresden, Germany Recruiting
• Department of Anaesthesiology and Intensive Care, National Medical Institute of the Ministry of Interior and Administration, Warsaw, Poland
  Warsaw, Poland Recruiting
• Critical Care Department, Parc Taulí Hospital Universitari, Institut d'Investigació I Innovació Parc Taulí (I3PT-CERCA), Sabadell, Spain
  Sabadell, Spain Recruiting
• Dipartimento di Scienze Chirurgiche e Diagnostiche Integrate, University of Genoa, Genoa, Italy
  Genova, Italy Not yet recruiting
• Department of Intensive Care Medicine. Hospital Universitario de La Princesa. Universidad Autonoma de Madrid, Madrid, Spain
  Madrid, Spain Not yet recruiting

Study contacts

• Principal investigator: Jakob Wittenstein — epartment of Anesthesiology and Intensive Care Medicine, Pulmonary Engineering Group, Faculty of Medicine and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany
• Study coordinator: Jakob Wittenstein, M.D.
• Email: jakob.wittenstein@ukdd.de
• Phone: +49 351 458 19777

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.