Recruiting

Observational Study

Sponsor:

Technische Universität Dresden

Code:

NCT05668637

Conditions

Invasive Mechanical Ventilation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Artificial Intelligence-based Decision support

Study Details

Brief 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. 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

Study ID

NCT05668637

Start date

Jan 1, 2023

Status verified date

Sep, 2025

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

• Patients receiving one-lung ventilation

Study Design

Enrollment

318542 participants

Anticipated

Interventions and Outcome Measures

Interventions

Artificial Intelligence-based Decision support

Decision support to optimise invasive mechanical ventilation settings

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 ]

Central Contacts and Locations

Central contacts

Locations

Cleveland Clinic Foundation, Cleveland, USA

Recruiting

Cleveland, Ohio, United States, 44195

More Information

Sponsor

Technische Universität Dresden

Last update posted

Apr 21, 2026

Last verified

Sep, 2025

Keywords

  • Mechanical ventilation
  • ventilator-induced lung injury
  • ARDS
  • artificial intelligence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Technische Universität Dresden on 2026-04-21.