Intelligent Lung Support in the Intensive Care Unit (IntelliLung)

Technische Universität Dresden

Status: Enrolling

Conditions: Mechanical Ventilation; Intensive Care Medicine

Treatments: Device: Artificial intelligence based decision support system (AI-DSS); software

Study type: Observational

Funder types: Other

Identifiers

NCT06595602

101057434 (Other Grant/Funding Number)

TUD-INTELL-086

Details and patient eligibility

About

The aim of this observational study is to test the IntelliLung decision support system based on artificial intelligence. This system is intended to help to set the ventilator. The study includes patients with and without ARDS (acute respiratory distress syndrome) who are receiving invasive mechanical ventilation, as well as patients with additional extracorporeal lung support. The study will be conducted in several centers.

The main question of the study:

How well do the mechanical ventilation settings of healthcare staff match the recommendations of the IntelliLung system?

Enrollment: 530 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male and female patients, age ⪰18 years
2. Written informed consent
3. Invasively mechanically ventilated patients expected to be intubated for more than 24 hours.

Exclusion criteria

1. Expected to die within ≤48 hours
2. Participation in an interventional mechanical ventilation trial
3. Mechanical Ventilation with a closed-loop ventilation mode
4. Persons dependent on the sponsor and/or investigator
5. Subjects who are currently imprisoned or otherwise in confinement ordered by law or other official authorities

Trial design

530 participants in 1 patient group

Invasively mechanically ventilated patients expected to stay ventilated for more than 24 h.

Treatment:

Device: Artificial intelligence based decision support system (AI-DSS); software