Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
530 participants
OBSERVATIONAL
2025-05-25
2027-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Invasively mechanically ventilated patients expected to stay ventilated for more than 24 h.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Written informed consent
3. Invasively mechanically ventilated patients expected to be intubated for more than 24 hours.
Exclusion Criteria
2. Participation in an interventional mechanical ventilation trial
3. Mechanical Ventilation with a closed-loop ventilation mode
4. Persons dependent on the sponsor and/or investigator
5. Subjects who are currently imprisoned or otherwise in confinement ordered by law or other official authorities
18 Years
ALL
No
Sponsors
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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
UNKNOWN
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
Technische Universität Dresden
OTHER
Responsible Party
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Principal Investigators
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Jakob Wittenstein
Role: PRINCIPAL_INVESTIGATOR
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
Locations
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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
Dresden, , Germany
Dipartimento di Scienze Chirurgiche e Diagnostiche Integrate, University of Genoa, Genoa, Italy
Genova, , Italy
Department of Anaesthesiology and Intensive Care, National Medical Institute of the Ministry of Interior and Administration, Warsaw, Poland
Warsaw, , Poland
Department of Intensive Care Medicine. Hospital Universitario de La Princesa. Universidad Autonoma de Madrid, Madrid, Spain
Madrid, , Spain
Critical Care Department, Parc Taulí Hospital Universitari, Institut d'Investigació I Innovació Parc Taulí (I3PT-CERCA), Sabadell, Spain
Sabadell, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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101057434
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
TUD-INTELL-086
Identifier Type: -
Identifier Source: org_study_id
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