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

Recruiting

• Conditions: Invasive Mechanical Ventilation

• Registration Number: NCT05668637
• Lead Sponsor: Technische Universität Dresden

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-09
• Study First Submitted QC: 2022-12-19
• Study First Posted: 2022-12-30
• Study Start: 2023-01-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-03-29
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 318542

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relative time of same device settings of the health care provider and the IntelliLung algorithm	From date of intubation to date of extubation or date of discharge, which ever came first, assessed up to 12 month

Trial Locations

Locations (8)

Better Care Sl; 🇪🇸 Sabadell, Spain

Cleveland Clinic Foundation, Cleveland, USA; 🇺🇸 Cleveland, Ohio, United States

Fundacion Publica Andaluza Progreso Y Salud; 🇪🇸 Sevilla, Spain

University Hospital Carl Gustav Carus Dresden; 🇩🇪 Dresden, Germany

Institut Fur Angewandte Informatik (Infai) Ev; 🇩🇪 Leipzig, Germany

Fundacio Parc Tauli; 🇪🇸 Sabadell, Spain

Inselspital, Universitätsspital Bern; 🇨🇭 Bern, Switzerland

Institut Mihajlo Pupin; 🇷🇸 Belgrade, Serbia