Intelligent Lung Support in the Intensive Care Unit (IntelliLung): study protocol for an international observational, prospective, multicentre study
BMJ Open, vol. 16, pp. e114851
Abstract
INTRODUCTION: Mechanical ventilation (MV) is lifesaving in the intensive care unit (ICU) but can cause complications if not individualised according to the patient's needs. Artificial intelligence (AI)-driven decision support systems (AI-DSS) may theoretically optimise MV settings. This international observational, prospective, multicentre study aims to validate the IntelliLung AI-DSS in real clinical environments. METHODS AND ANALYSIS: In this study, patients aged ≥18 years requiring invasive MV for >24 hours are included. The primary objective is to evaluate the agreement between IntelliLung AI-DSS MV recommendations and the ventilator settings implemented by healthcare providers. The IntelliLung AI-DSS continuously analyses patient-specific data, including respiratory mechanics and gas exchange, to recommend optimal MV parameters. The primary endpoints are the relative time of matching ventilator settings for each (1) positive end-expiratory pressure, (2) fraction of inspired oxygen, (3) respiratory rate and (4) tidal volume during volume-controlled ventilation or inspiratory pressure (Pinsp) during pressure-controlled ventilation. Secondary endpoints include assessments of ventilator-free days and clinical decision-making practices. Patient-centred outcomes, such as quality of life and psychological stress, are also evaluated. Data collection spans ICU stay and follow-up at 30 and 180 days after enrolment. This trial is the first to validate the IntelliLung AI-DSS in a prospective, real-world clinical setting by comparing recommendations given by the IntelliLung AI-DSS to local standards of care. The results of the trial will serve as a foundation for future interventional studies to assess the IntelliLung AI-DSS impact on patient outcomes and ICU workflows. The study addresses a critical gap in the application of AI to intensive care, advancing personalised and evidence-based MV management. ETHICS AND DISSEMINATION: The TUD Medical Faculty Ethical Committee for clinical research approved the study on 4 November 2024 (File number Mono-EK-27907202). Additionally, the institutional review board at Sabadell, Madrid and Warsaw approved the study. IntelliLung is designed in accordance with the principles of the Declaration of Helsinki. The final main results will be published in a highly ranked, peer-reviewed scientific journal taking into account the recommendations of the International Committee of Medical Journal Editors. TRIAL REGISTRATION NUMBER: NCT06595602.
Authors 27
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University Hospital Carl Gustav Carus · Technische Universität Dresden
Affiliation as printed
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
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University Hospital Carl Gustav Carus · Technische Universität Dresden
Affiliation as printed
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
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University Hospital Carl Gustav Carus · Technische Universität Dresden
Affiliation as printed
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
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University Hospital Carl Gustav Carus · Technische Universität Dresden
Affiliation as printed
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
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University Hospital Carl Gustav Carus · Technische Universität Dresden
Affiliation as printed
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
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University Hospital Carl Gustav Carus · Technische Universität Dresden
Affiliation as printed
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
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Ospedale Policlinico San Martino
Affiliation as printed
Anesthesia and Critical Care, San Martino Policlinico Hospital, Genoa, Italy
Anesthesia and Intensive Care, Ospedale Policlinico San Martino, IRCCS per l’Oncologia e le Neuroscienze, Genova, Italy
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Instituto de Salud Carlos III · Centro de Investigación Biomédica en Red de Enfermedades Respiratorias · Corporació Sanitària Parc Taulí · Institute of Research and Innovation Parc Tauli
Affiliation as printed
Centro Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain
Critical Care Department, Parc Taulí Hospital Universitari, Institut d’Investigació I Innovació Parc Taulí (I3PT-CERCA), Sabadell, Spain
Institut d’Investigació i Innovació Parc Taulí (I3PT-CERCA), Instituto de Salud Carlos III, Sabadelle, Spain
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Instituto de Salud Carlos III · Centro de Investigación Biomédica en Red de Enfermedades Respiratorias · Corporació Sanitària Parc Taulí · Institute of Research and Innovation Parc Tauli
Affiliation as printed
Centro Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain
Critical Care Department, Parc Taulí Hospital Universitari, Institut d’Investigació I Innovació Parc Taulí (I3PT-CERCA), Sabadell, Spain
Institut d’Investigació i Innovació Parc Taulí (I3PT-CERCA), Instituto de Salud Carlos III, Sabadelle, Spain
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Instituto de Salud Carlos III · Centro de Investigación Biomédica en Red de Enfermedades Respiratorias · Hospital Universitario de La Princesa · Institute of Research and Innovation Parc Tauli · Instituto de Investigación Sanitaria del Hospital Universitario de La Princesa · Universidad Autónoma de Madrid
Affiliation as printed
Centro Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain
Institut d’Investigació i Innovació Parc Taulí (I3PT-CERCA), Instituto de Salud Carlos III, Sabadelle, Spain
Instituto de Investigación Sanitaria Hospital Universitario la Princesa, Universitario la Princesa, Madrid, Spain
Intensive Care Medicine, Hospital Universitario de la Princesa. Universidad Autonoma de Madrid, Madrid, Spain
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Ministry of Interior and Administration · National Medical Institute of the Ministry of Interior and Administration
Affiliation as printed
Department of Anaesthesiology and Intensive Care, National Medical Institute Ministry of Interior and Administration, Warsaw, Poland
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Ministry of Interior and Administration · National Medical Institute of the Ministry of Interior and Administration
Affiliation as printed
Department of Anaesthesiology and Intensive Care, National Medical Institute Ministry of Interior and Administration, Warsaw, Poland
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Technische Universität Dresden
Affiliation as printed
Coordination Centre for Clinical Trials, Faculty of Medicine Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany
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Technische Universität Dresden
Affiliation as printed
Coordination Centre for Clinical Trials, Faculty of Medicine Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany
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Technische Universität Dresden
Affiliation as printed
Coordination Centre for Clinical Trials, Faculty of Medicine Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany
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Else Kröner Fresenius Center for Digital Health · Technische Universität Dresden
Affiliation as printed
Else Kroener Fresenius Center for Digital Health, TUD Dresden University of Technology, Dresden, Germany
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Institut Mihajlo Pupin · University of Belgrade
Affiliation as printed
Institute Mihajlo Pupin, University of Belgrade, Belgrade, Serbia
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Institut Mihajlo Pupin · University of Belgrade
Affiliation as printed
Institute Mihajlo Pupin, University of Belgrade, Belgrade, Serbia
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Institut Mihajlo Pupin · University of Belgrade
Affiliation as printed
Institute Mihajlo Pupin, University of Belgrade, Belgrade, Serbia
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Affiliation as printed
Nature-Inspired Machine Intelligence Group, Institute for Applied Informatics (InfAI), Dresden, Germany
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Affiliation as printed
Better Care SL Head of Engineering & Company Co-Founder, Better Care, Sabadelle, Spain
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Affiliation as printed
Rector, Medical University of Graz, Graz, Austria
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Affiliation as printed
Department of Information Theory and Data Analytics, RWTH Aachen University, Aachen, Germany
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The University of Melbourne · Hospital Israelita Albert Einstein · Austin Hospital · Monash University
Affiliation as printed
Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
Department of Critical Care Medicine, Hospital Israelita Albert Einstein, Sao Paulo, Brazil
Department of Critical Care, Melbourne Medical School, University of Melbourne, Austin Hospital, Melbourne, Victoria, Australia
Department of Intensive Care, Austin Hospital, Melbourne, Victoria, Australia
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Mahidol University · University of Oxford · Mahidol Oxford Tropical Medicine Research Unit · Amsterdam University Medical Centers · Medical University of Vienna
Affiliation as printed
Department of Anesthesia, General Intensive Care and Pain Management, Division of Cardiothoracic and Vascular Anesthesia & Critical Care Medicine, Medical University of Vienna, Vienna, Austria
Department of Intensive Care, University of Oxford, Oxford, UK
Intensive Care, Amsterdam University Medical Centers, Amsterdam, Netherlands
Mahidol Oxford Tropical Medicine Research Unit, Bangkok, Bangkok, Thailand
Nuffield Department of Medicine, Mahidol University, Bangkok, Thailand
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Cleveland Clinic · University Hospital Carl Gustav Carus · Technische Universität Dresden
Affiliation as printed
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
Division of Intensive Care and Resuscitation, Department of Anaesthesiology, Integrated Health Care Institute, Cleveland Clinic, Cleveland, Ohio, USA
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Jakob Wittenstein corresponding
University Hospital Carl Gustav Carus · Technische Universität Dresden
Affiliation as printed
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
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