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

Invasive Mechanical Ventilation Clinical Trial

— IntelliLung  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05668637
• Other study ID #: TUD-IntelliLung-Study-A
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: February 28, 2025

Study information

• Verified date: March 2024
• Source: Technische Universität Dresden
• Contact: Jakob Wittenstein, MD
• Phone: +49 351 458 19887
• Email: jakob.wittenstein[@]ukdd.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 318542
• Est. completion date: February 28, 2025
• Est. primary completion date: February 28, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients receiving one-lung ventilation

Related Conditions & MeSH terms

• Invasive Mechanical Ventilation

Intervention

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

Locations

Country	Name	City	State
Germany	University Hospital Carl Gustav Carus Dresden	Dresden
Germany	Institut Fur Angewandte Informatik (Infai) Ev	Leipzig
Serbia	Institut Mihajlo Pupin	Belgrade
Spain	Better Care Sl	Sabadell
Spain	Fundacio Parc Tauli	Sabadell
Spain	Fundacion Publica Andaluza Progreso Y Salud	Sevilla
Switzerland	Inselspital, Universitätsspital Bern	Bern
United States	Cleveland Clinic Foundation, Cleveland, USA	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Countries where clinical trial is conducted

United States,  Germany,  Serbia,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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