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Recruiting NCT05668637

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

Observational Invasive Mechanical Ventilation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Artificial Intelligence-based Decision support.
Who it may be relevant to
Registry conditions: Invasive Mechanical Ventilation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Germany, Serbia, Spain, Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • Other Artificial Intelligence-based Decision support
    Decision support to optimise invasive mechanical ventilation settings

Primary outcome measures

  • 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]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • Patients receiving one-lung ventilation

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Other

Study locations

Spain · 3 centers
  • Better Care Sl — Sabadell
  • Fundacio Parc Tauli — Sabadell
  • Fundacion Publica Andaluza Progreso Y Salud — Seville
Germany · 2 centers
  • University Hospital Carl Gustav Carus Dresden — Dresden
  • Institut Fur Angewandte Informatik (Infai) Ev — Leipzig
United States · 1 center
  • Cleveland Clinic Foundation, Cleveland, USA — Cleveland
Serbia · 1 center
  • Institut Mihajlo Pupin — Belgrade
Switzerland · 1 center
  • Inselspital, Universitätsspital Bern — Bern

Identifiers

NCT: NCT05668637 · TUD-IntelliLung-Study-A

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗