Research on clinical validation standard for intelligent ventilation mode of ventilator
10.3969/j.issn.1672-8270.2025.05.021
- VernacularTitle:呼吸机智能通气模式临床验证标准研究
- Author:
Wenting WANG
1
;
Meng WANG
1
;
Feifan ZHAO
1
;
Ning SHEN
1
Author Information
1. 北京大学第三医院呼吸与危重症医学科 北京 100191
- Publication Type:Journal Article
- Keywords:
Intelligent ventilation mode;
Mechanical ventilation;
Artificial intelligence(AI);
Validation standard
- From:
China Medical Equipment
2025;22(5):105-109
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To explore clinical validation standard for intelligent ventilation mode of ventilator and promote ventilator's clinical application.Methods:By real-time quantification of physiological parameters related to patient's ventilation and oxygenation,the change of respiratory function was analyzed,and the settings of ventilator's parameters were adjusted synchronously by using feedback signals to realize personalized support of ventilation.Combining with artificial intelligence(AI)technique,the clinical validation standard for intelligent ventilation mode was investigated from three aspects:requirements of clinical application and function of intelligent ventilation mode of ventilator,validation for platform of simulation experiment,and early clinical evaluation and interventional trials.Results:The clinical validation standards for intelligent ventilation mode of ventilator should meet the requirements of clinical application and function,and should complete preclinical evaluation of intelligent ventilation mode of ventilator,and assess safety and usability of that by the platform of simulation trials,and should conduct early clinical evaluations and interventional clinical trials so as to further assess safety and effectiveness of that before it was used formally in clinical application.Conclusion:The clinical validation standard of intelligent ventilation mode of ventilator can form standard validation process for intelligent ventilation mode,and promote the construction of standard validation platform,and facilitate clinical application and iterative optimization of intelligent ventilation mode,and improve medical quality.
