Evaluation and Further Development of an Artificial Intelligence-based Algorithm for Clinical Decision Support (IntelliLung)

April 16, 2026 updated by: Technische Universität Dresden

Retrospective Use of Patient Treatment Data for the Evaluation and Further Development of an Artificial Intelligence-based Algorithm for Clinical Decision Support in Invasive Mechanical Ventilation of Intensive Care Patients

Invasive mechanical ventilation is one of the most important and life-saving therapies in the intensive care unit (ICU). In most severe cases, extracorporeal lung support is initiated when mechanical ventilation is insufficient. However, mechanical ventilation is recognised as potentially harmful, because inappropriate mechanical ventilation settings in ICU patients are associated with organ damage, contributing to disease burden. Studies revealed that mechanical ventilation is often not provided adequately despite clear evidence and guidelines. Variables at the ventilator and extracorporeal lung support device can be set automatically using optimization functions and clinical recommendations, but the handling of experts may still deviate from those settings depending upon the clinical characteristics of individual patients. Artificial intelligence can be used to learn from those deviations as well as the patient's condition in an attempt to improve the combination of settings and accomplish lung support with reduced risk of damage.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

318542

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
        • Recruiting
        • University Hospital Carl Gustav Carus Dresden
      • Leipzig, Germany
        • Active, not recruiting
        • Institut Fur Angewandte Informatik (Infai) Ev
  • Serbia
      • Belgrade, Serbia
        • Active, not recruiting
        • Institut Mihajlo Pupin
  • Spain
      • Sabadell, Spain
        • Active, not recruiting
        • Better Care Sl
      • Sabadell, Spain
        • Completed
        • Fundacio Parc Tauli
      • Seville, Spain
        • Active, not recruiting
        • Fundacion Publica Andaluza Progreso Y Salud
  • Switzerland
      • Bern, Switzerland
        • Completed
        • Inselspital, Universitätsspital Bern
  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation, Cleveland, USA

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Intensive care patients receiving invasive mechanical ventilation

Description

Inclusion Criteria:

• Subjects who are 18 years or older and receive invasive mechanical ventilation for > 4 hours

Exclusion Criteria:

• Patients receiving one-lung ventilation

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

  • Observational Models: Other
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Relative time of same device settings of the health care provider and the IntelliLung algorithm
Time Frame: From date of intubation to date of extubation or date of discharge, which ever came first, assessed up to 12 month
From date of intubation to date of extubation or date of discharge, which ever came first, assessed up to 12 month

Collaborators and Investigators

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

Sponsor

Technische Universität Dresden

Investigators

  • Principal Investigator: Jakob Wittenstein, MD, University Hospital Carl Gustav Carus at Technischen Universität 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)

January 1, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

December 9, 2022

First Submitted That Met QC Criteria

December 19, 2022

First Posted (Actual)

December 30, 2022

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TUD-IntelliLung-Study-A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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