RecruitingNot Applicable

Intelligent Lung Support in the Intensive Care Unit

Germany, Italy, Poland530 participantsStarted 2025-05-25

Plain-language 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?

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male and female patients, age ⪰18 years
. Written informed consent
. Invasively mechanically ventilated patients expected to be intubated for more than 24 hours.

Exclusion criteria

. Expected to die within ≤48 hours
. Participation in an interventional mechanical ventilation trial
. Mechanical Ventilation with a closed-loop ventilation mode
. Persons dependent on the sponsor and/or investigator

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Relative time of same device settings of healthcare provider and IntelliLung AI-DSS related to the total IntelliLung AI-DSS running time

Timeframe: From enrollment to discharge from the intensive care unit or successful weaning from the ventilator, assessed up to 180 days

Trial details

NCT IDNCT06595602

SponsorTechnische Universität Dresden

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12

Contact for this trial

Jakob Wittenstein, M.D.

+49 351 458 19777 jakob.wittenstein@ukdd.de

View on ClinicalTrials.gov More Mechanical Ventilation trials