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Intelligent Lung Support in the Intensive Care Unit

NCT06595602 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 530

Last updated 2026-04-17

No results posted yet for this study

Summary

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?

Conditions

  • Intensive Care Medicine
  • Mechanical Ventilation

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Dipartimento di Scienze Chirurgiche e Diagnostiche Integrate, University of Genoa, Genoa, Italy

    collaborator UNKNOWN

  • Critical Care Department, Parc Taulí Hospital Universitari, Institut d'Investigació I Innovació Parc Taulí (I3PT-CERCA), Sabadell, Spain

    collaborator UNKNOWN

  • Department of Anaesthesiology and Intensive Care, National Medical Institute of the Ministry of Interior and Administration, Warsaw, Polan

    collaborator UNKNOWN

  • Department of Intensive Care Medicine. Hospital Universitario de La Princesa. Universidad Autonoma de Madrid, Madrid, Spain

    collaborator UNKNOWN

  • Department of Anesthesiology and Intensive Care Medicine, Pulmonary Engineering Group, Faculty of Medicine and University Hospital Carl Gustav Carus, TUD Dresde

    collaborator UNKNOWN

  • Technische Universität Dresden

    lead OTHER

Principal Investigators

  • 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

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-25
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Germany
  • Italy
  • Poland
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06595602 on ClinicalTrials.gov