Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-03-01 @ 10:06 AM
Study NCT ID:
NCT06595602
Status:
RECRUITING
Last Update Posted:
2025-09-26
First Post:
2024-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intelligent Lung Support in the Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 530}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2024-09-05', 'studyFirstSubmitQcDate': '2024-09-12', 'lastUpdatePostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative time of same device settings of healthcare provider and IntelliLung AI-DSS related to the total IntelliLung AI-DSS running time', 'timeFrame': 'From enrollment to discharge from the intensive care unit or successful weaning from the ventilator, assessed up to 180 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Invasive mechanical ventilation', 'Intensive care medicine', 'critical care medicine', 'artificial intelligence', 'decision support'], 'conditions': ['Mechanical Ventilation', 'Intensive Care Medicine']}, 'descriptionModule': {'briefSummary': '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.\n\nThe main question of the study:\n\nHow well do the mechanical ventilation settings of healthcare staff match the recommendations of the IntelliLung system?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Invasively mechanically ventilated, adult, acute respiratory distress syndrome (ARDS) and non-ARDS patients expected to stay intubated and ventilated for more than 24 hours.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male and female patients, age ⪰18 years\n2. Written informed consent\n3. Invasively mechanically ventilated patients expected to be intubated for more than 24 hours.\n\nExclusion Criteria:\n\n1. Expected to die within ≤48 hours\n2. Participation in an interventional mechanical ventilation trial\n3. Mechanical Ventilation with a closed-loop ventilation mode\n4. Persons dependent on the sponsor and/or investigator\n5. Subjects who are currently imprisoned or otherwise in confinement ordered by law or other official authorities'}, 'identificationModule': {'nctId': 'NCT06595602', 'acronym': 'IntelliLung', 'briefTitle': 'Intelligent Lung Support in the Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Technische Universität Dresden'}, 'officialTitle': 'Intelligent Lung Support in the Intensive Care Unit (IntelliLung): An Observational, Prospective, Multicentre Study', 'orgStudyIdInfo': {'id': 'TUD-INTELL-086'}, 'secondaryIdInfos': [{'id': '101057434', 'type': 'OTHER_GRANT', 'domain': 'European Union'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Invasively mechanically ventilated patients expected to stay ventilated for more than 24 h.', 'interventionNames': ['Device: Artificial intelligence based decision support system (AI-DSS); software']}], 'interventions': [{'name': 'Artificial intelligence based decision support system (AI-DSS); software', 'type': 'DEVICE', 'description': "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.\n\nThe 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.", 'armGroupLabels': ['Invasively mechanically ventilated patients expected to stay ventilated for more than 24 h.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01307', 'city': 'Dresden', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jakob Wittenstein, MD', 'role': 'CONTACT', 'email': 'jakob.wittenstein@ukdd.de', 'phone': '+49 351 458 19777'}], 'facility': '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', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Genova', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Lorenzo Ball', 'role': 'CONTACT', 'email': 'lorenzo.ball@unige.it'}], 'facility': 'Dipartimento di Scienze Chirurgiche e Diagnostiche Integrate, University of Genoa, Genoa, Italy', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Warsaw', 'status': 'NOT_YET_RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Konstanty Szuldrzynski', 'role': 'CONTACT', 'email': 'konstanty.szuldrzynski@pimmswia.gov.pl'}], 'facility': 'Department of Anaesthesiology and Intensive Care, National Medical Institute of the Ministry of Interior and Administration, Warsaw, Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Madrid', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Fernando Suarez Sipmann', 'role': 'CONTACT', 'email': 'fsuarezsipmann@gmail.com'}], 'facility': 'Department of Intensive Care Medicine. Hospital Universitario de La Princesa. Universidad Autonoma de Madrid, Madrid, Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Sabadell', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Lluis Blanch', 'role': 'CONTACT', 'email': 'lblanch@tauli.cat'}], 'facility': "Critical Care Department, Parc Taulí Hospital Universitari, Institut d'Investigació I Innovació Parc Taulí (I3PT-CERCA), Sabadell, Spain", 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}], 'centralContacts': [{'name': 'Jakob Wittenstein, M.D.', 'role': 'CONTACT', 'email': 'jakob.wittenstein@ukdd.de', 'phone': '+49 351 458 19777'}, {'name': 'Raphael Theilen', 'role': 'CONTACT', 'email': 'raphael.theilen@ukdd.de', 'phone': '+49 351 458 19777'}], 'overallOfficials': [{'name': 'Jakob Wittenstein', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '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'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technische Universität Dresden', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dipartimento di Scienze Chirurgiche e Diagnostiche Integrate, University of Genoa, Genoa, Italy', 'class': 'UNKNOWN'}, {'name': "Critical Care Department, Parc Taulí Hospital Universitari, Institut d'Investigació I Innovació Parc Taulí (I3PT-CERCA), Sabadell, Spain", 'class': 'UNKNOWN'}, {'name': 'Department of Anaesthesiology and Intensive Care, National Medical Institute of the Ministry of Interior and Administration, Warsaw, Polan', 'class': 'UNKNOWN'}, {'name': 'Department of Intensive Care Medicine. Hospital Universitario de La Princesa. Universidad Autonoma de Madrid, Madrid, Spain', 'class': 'UNKNOWN'}, {'name': 'Department of Anesthesiology and Intensive Care Medicine, Pulmonary Engineering Group, Faculty of Medicine and University Hospital Carl Gustav Carus, TUD Dresde', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}