Intelligent Lung Support in the Intensive Care Unit
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTechnische Universität Dresden
About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female patients, age ⪰18 years
Written informed consent
Invasively mechanically ventilated patients expected to be intubated for more than 24 hours.
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Artificial intelligence based decision support system (AI-DSS); software
DeviceThe 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.
Treatment groups
530 Participants
are divided into 1 treatment groupGroup A: Invasively mechanically ventilated patients expected to stay ventilated for more than 24 h.1 intervention
Trial outcomes
Primary outcomes
1
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 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Technische Universität Dresden
Lead sponsor
Dipartimento di Scienze Chirurgiche e Diagnostiche Integrate, University of Genoa, Genoa, Italy
Collaborator
Critical Care Department, Parc Taulí Hospital Universitari, Institut d'Investigació I Innovació Parc Taulí (I3PT-CERCA), Sabadell, Spain
Collaborator
Department of Anaesthesiology and Intensive Care, National Medical Institute of the Ministry of Interior and Administration, Warsaw, Polan
Collaborator
Department of Intensive Care Medicine. Hospital Universitario de La Princesa. Universidad Autonoma de Madrid, Madrid, Spain
Collaborator
Department of Anesthesiology and Intensive Care Medicine, Pulmonary Engineering Group, Faculty of Medicine and University Hospital Carl Gustav Carus, TUD Dresde
Collaborator
Source ClinicalTrials.gov