Intelligent Lung Support in the Intensive Care Unit
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Artificial intelligence based decision support system (AI-DSS); software.
- Who it may be relevant to
- Registry conditions: Mechanical Ventilation, Intensive Care Medicine. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany, Italy, Poland, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Intelligent Lung Support in the Intensive Care Unit (IntelliLung): An Observational, Prospective, Multicentre Study
Overview
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?
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, b
Primary outcome measures
- 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]
Eligibility criteria
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
- Subjects who are currently imprisoned or otherwise in confinement ordered by law or other official authorities
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 2 centers
- Department of Intensive Care Medicine. Hospital Universitario de La Princesa. Universidad — Madrid
- Critical Care Department, Parc Taulí Hospital Universitari, Institut d'Investigació I Inno — Sabadell
Germany · 1 center
- Department of Anesthesiology and Intensive Care Medicine, Pulmonary Engineering Group, Fac — Dresden
Italy · 1 center
- Dipartimento di Scienze Chirurgiche e Diagnostiche Integrate, University of Genoa, Genoa, — Genova
Poland · 1 center
- Department of Anaesthesiology and Intensive Care, National Medical Institute of the Minist — Warsaw
Identifiers
NCT: NCT06595602 · TUD-INTELL-086 · 101057434