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Evaluation and Further Development of an Artificial Intelligence-based Algorithm for Clinical Decision Support

NCT ID: NCT05668637

Last Updated: 2025-09-26

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

318542 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2026-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Invasive Mechanical Ventilation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

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Artificial Intelligence-based Decision support

Decision support to optimise invasive mechanical ventilation settings

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

• Subjects who are 18 years or older and receive invasive mechanical ventilation for \> 4 hours

Exclusion Criteria

• Patients receiving one-lung ventilation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technische Universität Dresden

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jakob Wittenstein, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Carl Gustav Carus at Technischen Universität Dresden, Germany

Locations

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Cleveland Clinic Foundation, Cleveland, USA

Cleveland, Ohio, United States

Site Status RECRUITING

University Hospital Carl Gustav Carus Dresden

Dresden, , Germany

Site Status RECRUITING

Institut Fur Angewandte Informatik (Infai) Ev

Leipzig, , Germany

Site Status ACTIVE_NOT_RECRUITING

Institut Mihajlo Pupin

Belgrade, , Serbia

Site Status ACTIVE_NOT_RECRUITING

Better Care Sl

Sabadell, , Spain

Site Status ACTIVE_NOT_RECRUITING

Fundacio Parc Tauli

Sabadell, , Spain

Site Status RECRUITING

Fundacion Publica Andaluza Progreso Y Salud

Seville, , Spain

Site Status ACTIVE_NOT_RECRUITING

Inselspital, Universitätsspital Bern

Bern, , Switzerland

Site Status RECRUITING

Countries

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United States Germany Serbia Spain Switzerland

Central Contacts

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Jakob Wittenstein, MD

Role: CONTACT

[email protected]
+49 351 458 19887

Thea Koch, PhD

Role: CONTACT

[email protected]

Other Identifiers

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TUD-IntelliLung-Study-A

Identifier Type: -

Identifier Source: org_study_id

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