Smart lung support for adults on a ventilator in the ICU
Intelligent Lung Support in the Intensive Care Unit (IntelliLung): An Observational, Prospective, Multicentre Study
This observational project will test the IntelliLung AI decision support system in adults receiving invasive mechanical ventilation to see if its recommended ventilator settings match what clinicians actually choose.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 530 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Technische Universität Dresden Academic / other |
| Locations | 5 sites (Dresden and 4 other locations) |
| Trial ID | NCT06595602 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18 years) who are invasively mechanically ventilated, expected to remain intubated for more than 24 hours, and who (or whose proxy) can provide informed consent.
Not a fit: Patients expected to die within 48 hours, those on closed-loop ventilation modes, participants in interventional mechanical ventilation trials, or persons unable to consent (including prisoners) are unlikely to receive benefit from participation.
Why it matters
Potential benefit: If successful, IntelliLung could help standardize ventilator settings and reduce ventilator-induced lung injury, potentially improving patient outcomes.
How similar studies have performed: Prior feasibility and algorithm-development work on AI-based ventilator decision support has shown promise in simulations and small single-center series, but robust multicenter clinical outcome data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Dresden and 4 other locations
- 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)
- Dipartimento di Scienze Chirurgiche e Diagnostiche Integrate, University of Genoa, Genoa, Italy — Genova, Italy (Not_yet_recruiting)
- Department of Anaesthesiology and Intensive Care, National Medical Institute of the Ministry of Interior and Administration, Warsaw, Poland — Warsaw, Poland (Recruiting)
- Department of Intensive Care Medicine. Hospital Universitario de La Princesa. Universidad Autonoma de Madrid, Madrid, Spain — Madrid, Spain (Not_yet_recruiting)
- Critical Care Department, Parc Taulí Hospital Universitari, Institut d'Investigació I Innovació Parc Taulí (I3PT-CERCA), Sabadell, Spain — Sabadell, Spain (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.