NCT06595602

Intelligent Lung Support in the Intensive Care Unit

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 530 (estimated)
• Sponsor: Technische Universität Dresden · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Mechanical Ventilation
• Intensive Care Medicine

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-05-25
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2024-09-19
• Last updated: 2026-04-17

Locations

5 sites across 4 countries: Germany, Italy, Poland, Spain