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Clinical Trials/NCT05668637
NCT05668637RecruitingNot Applicable

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

Technische Universität Dresden13 sites in 5 countries318,542 target enrollmentStarted: January 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
318,542
Locations
13
Primary Endpoint
Relative time of same device settings of the health care provider and the IntelliLung algorithm

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Patients receiving one-lung ventilation

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (13)

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