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Recruiting NCT06595602

Intelligent Lung Support in the Intensive Care Unit

Conditions: Mechanical Ventilation Intensive Care Medicine

Sponsor: Technische Universität Dresden

trial.available_in: БГ
Overview
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?
Who can participate
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
Interventions
Artificial intelligence based decision support system (AI-DSS); software
DEVICE
Locations 5
Germany (1)
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
Italy (1)
Dipartimento di Scienze Chirurgiche e Diagnostiche Integrate, University of Genoa, Genoa, Italy
Genova
NOT_YET_RECRUITING
Poland (1)
Department of Anaesthesiology and Intensive Care, National Medical Institute of the Ministry of Interior and Administration, Warsaw, Poland
Warsaw
Spain (2)
Department of Intensive Care Medicine. Hospital Universitario de La Princesa. Universidad Autonoma de Madrid, Madrid, Spain
Madrid
NOT_YET_RECRUITING
Fernando Suarez Sipmann
Critical Care Department, Parc Taulí Hospital Universitari, Institut d'Investigació I Innovació Parc Taulí (I3PT-CERCA), Sabadell, Spain
Sabadell
Lluis Blanch
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
25.05.2025
Completion date
01.12.2027
Registry ID
NCT06595602
Source
clinicaltrials.gov
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