Invasive Mechanical VentilationIntelliLungNCT05668637
Evaluation and Further Development of an Artificial Intelligence-based Algorithm for Clinical Decision Support
An observational study of Invasive Mechanical Ventilation, run by Technische Universität Dresden at 8 sites in 5 countries.
Trial summary
Invasive mechanical ventilation is one of the most important and life-saving therapies in the intensive care unit (ICU). In most severe cases, extracorporeal lung support is initiated when mechanical ventilation is insufficient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Mechanical Ventilation
- What is being tested?
- Artificial Intelligence-based Decision support
- How many people
- 318,542 participants
- Where
- 8 sitesin 5 countries
- Study dates
- 1 Jan 2023to 1 Sep 2026
- 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
- Adult, Older adult
Study population: Intensive care patients receiving invasive mechanical ventilation
Who may be able to join
- Subjects who are 18 years or older and receive invasive mechanical ventilation for > 4 hours
Who cannot join
- Patients receiving one-lung ventilation
Trial locations and contacts
8 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
Thea Koch, PhD contact
8 sites in 5 countries
Spain3 sites
- Active, not recruiting
Better Care Sl
Sabadell
- Completed
Fundacio Parc Tauli
Sabadell
- Active, not recruiting
Fundacion Publica Andaluza Progreso Y Salud
Seville
Germany2 sites, 1 recruiting
- Recruiting
University Hospital Carl Gustav Carus Dresden
Dresden
- Active, not recruiting
Institut Fur Angewandte Informatik (Infai) Ev
Leipzig
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic Foundation, Cleveland, USA
Cleveland, Ohio, 44195
About this study
Official title: Retrospective Use of Patient Treatment Data for the Evaluation and Further Development of an Artificial Intelligence-based Algorithm for Clinical Decision Support in Invasive Mechanical Ventilation of Intensive Care Patients
Invasive mechanical ventilation is one of the most important and life-saving therapies in the intensive care unit (ICU). In most severe cases, extracorporeal lung support is initiated when mechanical ventilation is insufficient. However, mechanical ventilation is recognised as potentially harmful, because inappropriate mechanical ventilation settings in ICU patients are associated with organ damage, contributing to disease burden. Studies revealed that mechanical ventilation is often not provided adequately despite clear evidence and guidelines. Variables at the ventilator and extracorporeal lung support device can be set automatically using optimization functions and clinical recommendations, but the handling of experts may still deviate from those settings depending upon the clinical characteristics of individual patients. Artificial intelligence can be used to learn from those deviations as well as the patient's condition in an attempt to improve the combination of settings and accomplish lung support with reduced risk of damage.
- Conditions
- Invasive Mechanical Ventilation
- Being tested
- Artificial Intelligence-based Decision support
- Keywords
- Mechanical ventilation, ventilator-induced lung injury, ARDS, artificial intelligence
- Medical subject headings
- Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Intelligence-based Decision supportOther
Decision support to optimise invasive mechanical ventilation settings
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative time of same device settings of the health care provider and the IntelliLung algorithm
Measured: From date of intubation to date of extubation or date of discharge, which ever came first, assessed up to 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2022
- Study start1 Jan 2023
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 318,542 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jakob Wittenstein, MD, Principal investigator, University Hospital Carl Gustav Carus at Technischen Universität Dresden, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05668637
- Sponsor's protocol ID
- TUD-IntelliLung-Study-A
- Acronym
- IntelliLung
- Status last verified
- Sep 2025
- First submitted
- 9 Dec 2022
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Use of Patient Treatment Data for the Evaluation and Further Development of an Artificial Intelligence-based Algorithm for Clinical Decision Support in Invasive Mechanical Ventilation of Intensive Care Patients
- ClinicalTrials.gov ID
- NCT05668637
- Acronym / sponsor ID
- IntelliLung / TUD-IntelliLung-Study-A
- Conditions
- Invasive Mechanical Ventilation
- Keywords
- Mechanical ventilation, ventilator-induced lung injury, ARDS, artificial intelligence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 318,542 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 30 Dec 2022 (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.
Invasive mechanical ventilation is one of the most important and life-saving therapies in the intensive care unit (ICU). In most severe cases, extracorporeal lung support is initiated when mechanical ventilation is insufficient. However, mechanical ventilation is recognised as potentially harmful, because inappropriate mechanical ventilation settings in ICU patients are associated with organ damage, contributing to disease burden. Studies revealed that mechanical ventilation is often not provided adequately despite clear evidence and guidelines. Variables at the ventilator and extracorporeal lung support device can be set automatically using optimization functions and clinical recommendations, but the handling of experts may still deviate from those settings depending upon the clinical characteristics of individual patients. Artificial intelligence can be used to learn from those deviations as well as the patient's condition in an attempt to improve the combination of settings and accomplish lung support with reduced risk of damage.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Intensive care patients receiving invasive mechanical ventilation
Key inclusion criteria (1 listed)
- Subjects who are 18 years or older and receive invasive mechanical ventilation for > 4 hours
Key exclusion criteria (1 listed)
- Patients receiving one-lung ventilation
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 supportDecision support to optimise invasive mechanical ventilation settings | Other | – |
Primary outcome
Relative time of same device settings of the health care provider and the IntelliLung algorithm
Time frame: From date of intubation to date of extubation or date of discharge, which ever came first, assessed up to 12 month
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 21 Apr 2026.
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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.
Thea Koch, PhD contact
Jakob Wittenstein, MD principal investigator
University Hospital Carl Gustav Carus at Technischen Universität Dresden, Germany
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Mechanical Ventilation, run by Technische Universität Dresden at 8 sites in 5 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 1 inclusion and 1 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 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain, Germany, United States, Serbia, Switzerland. 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, MD (+49 351 458 19887, 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 the health care provider and the IntelliLung algorithm (time frame: From date of intubation to date of extubation or date of discharge, which ever came first, assessed up to 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Apr 2026.