Intelligent Lung Support in the Intensive Care Unit (IntelliLung)

April 16, 2026 updated by: Technische Universität Dresden

Intelligent Lung Support in the Intensive Care Unit (IntelliLung): An Observational, Prospective, Multicentre Study

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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

530

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Dresden, Germany, 01307
        • Recruiting
        • 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
        • Contact:
  • Italy
      • Genova, Italy
        • Not yet recruiting
        • Dipartimento di Scienze Chirurgiche e Diagnostiche Integrate, University of Genoa, Genoa, Italy
        • Contact:
  • Poland
      • Warsaw, Poland
        • Recruiting
        • Department of Anaesthesiology and Intensive Care, National Medical Institute of the Ministry of Interior and Administration, Warsaw, Poland
        • Contact:
  • Spain
      • Madrid, Spain
        • Not yet recruiting
        • Department of Intensive Care Medicine. Hospital Universitario de La Princesa. Universidad Autonoma de Madrid, Madrid, Spain
        • Contact:
      • Sabadell, Spain
        • Recruiting
        • Critical Care Department, Parc Taulí Hospital Universitari, Institut d'Investigació I Innovació Parc Taulí (I3PT-CERCA), Sabadell, Spain
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Invasively mechanically ventilated, adult, acute respiratory distress syndrome (ARDS) and non-ARDS patients expected to stay intubated and ventilated for more than 24 hours.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Invasively mechanically ventilated patients expected to stay ventilated for more than 24 h.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Relative time of same device settings of healthcare provider and IntelliLung AI-DSS related to the total IntelliLung AI-DSS running time
Time Frame: From enrollment to discharge from the intensive care unit or successful weaning from the ventilator, assessed up to 180 days
From enrollment to discharge from the intensive care unit or successful weaning from the ventilator, assessed up to 180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technische Universität Dresden

Collaborators

Dipartimento di Scienze Chirurgiche e Diagnostiche Integrate, University of Genoa, Genoa, Italy
Critical Care Department, Parc Taulí Hospital Universitari, Institut d'Investigació I Innovació Parc Taulí (I3PT-CERCA), Sabadell, Spain
Department of Anaesthesiology and Intensive Care, National Medical Institute of the Ministry of Interior and Administration, Warsaw, Polan
Department of Intensive Care Medicine. Hospital Universitario de La Princesa. Universidad Autonoma de Madrid, Madrid, Spain
Department of Anesthesiology and Intensive Care Medicine, Pulmonary Engineering Group, Faculty of Medicine and University Hospital Carl Gustav Carus, TUD Dresde

Investigators

  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

September 5, 2024

First Submitted That Met QC Criteria

September 12, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TUD-INTELL-086
  • 101057434 (Other Grant/Funding Number: European Union)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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