Intelligent Lung Support in the Intensive Care Unit (IntelliLung): An Observational, Prospective, Multicentre Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 530
- 试验地点
- 8
- 主要终点
- Relative time of same device settings of healthcare provider and IntelliLung AI-DSS related to the total IntelliLung AI-DSS running time
研究概览
简要总结
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?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients, age ⪰18 years
- •Written informed consent
- •Invasively mechanically ventilated patients expected to be intubated for more than 24 hours.
排除标准
- •Expected to die within ≤48 hours
- •Participation in an interventional mechanical ventilation trial
- •Mechanical Ventilation with a closed-loop ventilation mode
- •Persons dependent on the sponsor and/or investigator
- •Subjects who are currently imprisoned or otherwise in confinement ordered by law or other official authorities
研究组 & 干预措施
Invasively mechanically ventilated patients expected to stay ventilated for more than 24 h.
干预措施: Artificial intelligence based decision support system (AI-DSS); software (Device)
结局指标
主要结局
Relative time of same device settings of healthcare provider and IntelliLung AI-DSS related to the total IntelliLung AI-DSS running time
时间窗: From enrollment to discharge from the intensive care unit or successful weaning from the ventilator, assessed up to 180 days
次要结局
未报告次要终点