Artificial intelligence based decision support system (AI-DSS); software: The device is intended for monitoring and recommending ventilator settings, ventilation mode to qualified Intensive Care Unit (ICU) health care professionals (HCP). This is for medical indications that require invasive mechanical ventilation of the respiratory system in the ICU under international / EU guidelines. The device receives clinical data via the ICU's data integration platform that includes patient physical and demographic data as well as current vital signs, ventilation parameters, blood gas analysis, general blood laboratory reports, fluid balance and medication. Prediction models based on artificial intelligence algorithms are used to deduce therapy suggestions from received data. The algorithm is carried out on a secured cloud platform.
The aim of this observational study is to test the IntelliLung decision support system based on artificial intelligence. This system is intended to help to set the ventilator. The study includes patients with and without ARDS (acute respiratory distress syndrome) who are receiving invasive mechanical ventilation, as well as patients with additional extracorporeal lung support. The study will be conducted in several centers.
The main question of the study:
How well do the mechanical ventilation settings of healthcare staff match the recommendations of the IntelliLung system?
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06595602 on ClinicalTrials.gov ↗ ← All trials in Germany