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| ID | Type | Description | Link |
|---|---|---|---|
| 101057434 | Other Grant/Funding Number | European Union |
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| Name | Class |
|---|---|
| Dipartimento di Scienze Chirurgiche e Diagnostiche Integrate, University of Genoa, Genoa, Italy | UNKNOWN |
| Critical Care Department, Parc Taulí Hospital Universitari, Institut d'Investigació I Innovació Parc Taulí (I3PT-CERCA), Sabadell, Spain | UNKNOWN |
| Department of Anaesthesiology and Intensive Care, National Medical Institute of the Ministry of Interior and Administration, Warsaw, Polan |
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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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Invasively mechanically ventilated patients expected to stay ventilated for more than 24 h. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artificial intelligence based decision support system (AI-DSS); software | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Relative time of same device settings of healthcare provider and IntelliLung AI-DSS related to the total IntelliLung AI-DSS running time | From enrollment to discharge from the intensive care unit or successful weaning from the ventilator, assessed up to 180 days |
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Inclusion Criteria:
Exclusion Criteria:
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Invasively mechanically ventilated, adult, acute respiratory distress syndrome (ARDS) and non-ARDS patients expected to stay intubated and ventilated for more than 24 hours.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jakob Wittenstein, M.D. | Contact | +49 351 458 19777 | jakob.wittenstein@ukdd.de | |
| Raphael Theilen | Contact | +49 351 458 19777 | raphael.theilen@ukdd.de |
| Name | Affiliation | Role |
|---|---|---|
| Jakob Wittenstein | epartment of Anesthesiology and Intensive Care Medicine, Pulmonary Engineering Group, Faculty of Medicine and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Intensive Care Medicine, Pulmonary Engineering Group, Faculty of Medicine and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany | Recruiting | Dresden | 01307 |
IPD as de-identified and anonymised data, will be shared in the open-access research data repository of Saxon universities OpARA (Open Access Repository and Archive, https://opara.zih.tu-dresden.de/).
Starting 6 months after publication
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| Department of Intensive Care Medicine. Hospital Universitario de La Princesa. Universidad Autonoma de Madrid, Madrid, Spain | UNKNOWN |
| Department of Anesthesiology and Intensive Care Medicine, Pulmonary Engineering Group, Faculty of Medicine and University Hospital Carl Gustav Carus, TUD Dresde | UNKNOWN |
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| Germany |
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| Dipartimento di Scienze Chirurgiche e Diagnostiche Integrate, University of Genoa, Genoa, Italy | Not yet recruiting | Genova | Italy |
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| Department of Anaesthesiology and Intensive Care, National Medical Institute of the Ministry of Interior and Administration, Warsaw, Poland | Recruiting | Warsaw | Poland |
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| Department of Intensive Care Medicine. Hospital Universitario de La Princesa. Universidad Autonoma de Madrid, Madrid, Spain | Not yet recruiting | Madrid | Spain |
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| Critical Care Department, Parc Taulí Hospital Universitari, Institut d'Investigació I Innovació Parc Taulí (I3PT-CERCA), Sabadell, Spain | Recruiting | Sabadell | Spain |
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