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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05668637
Other study ID # TUD-IntelliLung-Study-A
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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