Mechanical VentilationIntelliLungNCT06595602
Intelligent Lung Support in the Intensive Care Unit
An observational study of Mechanical Ventilation and Intensive Care Medicine, run by Technische Universität Dresden at 5 sites in 4 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation, Intensive Care Medicine
- What is being tested?
- Artificial intelligence based decision support system (AI-DSS); software
- Type of treatment
- Medical device
- How many people
- 530 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 25 May 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- Male and female patients, age ⪰18 years
- Written informed consent
- Invasively mechanically ventilated patients expected to be intubated for more than 24 hours.
Who cannot join
- 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
- Subjects who are currently imprisoned or otherwise in confinement ordered by law or other official authorities
Trial locations and contacts
5 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 4 countries
Spain2 sites, 2 recruiting
- Not yet recruiting
Department of Intensive Care Medicine. Hospital Universitario de La Princesa. Universidad Autonoma de Madrid, Madrid, Spain
Madrid
Fernando Suarez Sipmann, fsuarezsipmann@gmail.com
- Recruiting
Critical Care Department, Parc Taulí Hospital Universitari, Institut d'Investigació I Innovació Parc Taulí (I3PT-CERCA), Sabadell, Spain
Sabadell
Lluis Blanch, lblanch@tauli.cat
Germany1 site, 1 recruiting
- Recruiting
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, 01307
Jakob Wittenstein, MD, +49 351 458 19777, jakob.wittenstein@ukdd.de
Italy1 site, 1 recruiting
- Not yet recruiting
Dipartimento di Scienze Chirurgiche e Diagnostiche Integrate, University of Genoa, Genoa, Italy
Genova
Lorenzo Ball, lorenzo.ball@unige.it
Poland1 site, 1 recruiting
- Recruiting
Department of Anaesthesiology and Intensive Care, National Medical Institute of the Ministry of Interior and Administration, Warsaw, Poland
Warsaw
Konstanty Szuldrzynski, konstanty.szuldrzynski@pimmswia.gov.pl
About this study
Official title: Intelligent Lung Support in the Intensive Care Unit (IntelliLung): An Observational, Prospective, Multicentre Study
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?
- Conditions
- Mechanical Ventilation, Intensive Care Medicine
- Being tested
- Artificial intelligence based decision support system (AI-DSS); software
- Keywords
- Invasive mechanical ventilation, Intensive care medicine, critical care medicine, artificial intelligence, decision support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial intelligence based decision support system (AI-DSS); softwareDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Invasively mechanically ventilated patients expected to stay ventilated for more than 24 h. | Not described Receives: Device: Artificial intelligence based decision support system (AI-DSS); software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative time of same device settings of healthcare provider and IntelliLung AI-DSS related to the total IntelliLung AI-DSS running time
Measured: From enrollment to discharge from the intensive care unit or successful weaning from the ventilator, assessed up to 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start25 May 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 530 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Dipartimento di Scienze Chirurgiche e Diagnostiche Integrate, University of Genoa, Genoa, Italy, Critical Care Department, Parc Taulí Hospital Universitari, Institut d'Investigació I Innovació Parc Taulí (I3PT-CERCA), Sabadell, Spain, Department of Anaesthesiology and Intensive Care, National Medical Institute of the Ministry of Interior and Administration, Warsaw, Polan, Department of Intensive Care Medicine. Hospital Universitario de La Princesa. Universidad Autonoma de Madrid, Madrid, Spain, Department of Anesthesiology and Intensive Care Medicine, Pulmonary Engineering Group, Faculty of Medicine and University Hospital Carl Gustav Carus, TUD Dresde
- Responsible party
- Sponsor
- Investigators
- Jakob Wittenstein, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595602
- Sponsor's protocol ID
- TUD-INTELL-086
- Other IDs
- 101057434
- Acronym
- IntelliLung
- Status last verified
- Apr 2026
- First submitted
- 5 Sep 2024
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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/).
Publications
Theilen R, Huhle R, Scharffenberg M, Fischer F, Kramer T, Koch T, Ball L, Blanch L, Sarlabous L, Suarez-Sipmann F, Szuldrzynski K, Jankowski M, Kalinka J, Trips E, Djawid B, Tsurkan S, Janev V, Nenadovic M, Paunovic D, Vahdati S, Castells JM, Kurz A, Hallawa A, Serpa Neto A, Schultz MJ, Gama de Abreu M, Wittenstein J; IntelliLung Consortium. Intelligent Lung Support in the Intensive Care Unit (IntelliLung): study protocol for an international observational, prospective, multicentre study. BMJ Open. 2026 Sep 23;16(9):e114851. doi: 10.1136/bmjopen-2025-114851.
PubMed 42778255
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intelligent Lung Support in the Intensive Care Unit (IntelliLung): An Observational, Prospective, Multicentre Study
- ClinicalTrials.gov ID
- NCT06595602
- Acronym / sponsor ID
- IntelliLung / TUD-INTELL-086
- Conditions
- Mechanical Ventilation, Intensive Care Medicine
- Keywords
- Invasive mechanical ventilation, Intensive care medicine, critical care medicine, artificial intelligence, decision support
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 530 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Dipartimento di Scienze Chirurgiche e Diagnostiche Integrate, University of Genoa, Genoa, Italy, Critical Care Department, Parc Taulí Hospital Universitari, Institut d'Investigació I Innovació Parc Taulí (I3PT-CERCA), Sabadell, Spain, Department of Anaesthesiology and Intensive Care, National Medical Institute of the Ministry of Interior and Administration, Warsaw, Polan, Department of Intensive Care Medicine. Hospital Universitario de La Princesa. Universidad Autonoma de Madrid, Madrid, Spain, Department of Anesthesiology and Intensive Care Medicine, Pulmonary Engineering Group, Faculty of Medicine and University Hospital Carl Gustav Carus, TUD Dresde
- Study start
- 25 May 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Invasively mechanically ventilated patients expected to stay ventilated for more than 24 h. | – | Device: Artificial intelligence based decision support system (AI-DSS); software |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (3 listed)
- Male and female patients, age ⪰18 years
- Written informed consent
- Invasively mechanically ventilated patients expected to be intubated for more than 24 hours.
Key exclusion criteria (5 listed)
- 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
- Subjects who are currently imprisoned or otherwise in confinement ordered by law or other official authorities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artificial intelligence based decision support system (AI-DSS); softwareThe 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. | Device | Invasively mechanically ventilated patients expected to stay ventilated for more than 24 h. |
Primary outcome
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 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Derived from this study: PubMed 42778255Theilen R, Huhle R, Scharffenberg M, Fischer F, Kramer T, Koch T, Ball L, Blanch L, Sarlabous L, Suarez-Sipmann F, Szuldrzynski K, Jankowski M, Kalinka J, Trips E, Djawid B, Tsurkan S, Janev V, Nenadovic M, Paunovic D, Vahdati S, Castells JM, Kurz A, Hallawa A, Serpa Neto A, Schultz MJ, Gama de Abreu M, Wittenstein J; IntelliLung Consortium. Intelligent Lung Support in the Intensive Care Unit (IntelliLung): study protocol for an international observational, prospective, multicentre study. BMJ Open. 2026 Sep 23;16(9):e114851. doi: 10.1136/bmjopen-2025-114851.
- Individual participant dataSharing planned: Yes. 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/).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jakob Wittenstein 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
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation and Intensive Care Medicine, run by Technische Universität Dresden at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain, Germany, Italy, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jakob Wittenstein, M.D. (+49 351 458 19777, jakob.wittenstein@ukdd.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06595602, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.