Diagnostic Application of AI-ROSE in Severe Pneumonia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Severe Pneumonia, Bacterial Infections. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Diagnostic Application of Microbiological Fluorescence Rapid On-site Evaluation Combined With Artificial Intelligence in Severe Pneumonia: a Multi-center Prospective Study
Overview
AI-ROSE is an innovative immunofluorescence staining combined with artificial intelligence image analysis technology that uses a fully automated fluorescence microscope to image pathogens in real time. AI algorithms automatically identify pathogen types (such as bacteria, fungi, etc.) and cellular backgrounds, quickly interpret results, and automatically issue color graphic reports for clinical doctors to take earlier and more accurate targeted treatment for critically ill patients. This study used bronchoalveolar lavage fluid as a biological sample and compared it with traditional examination methods to analyze the diagnostic accuracy and clinical practicality of AI-ROSE in patients with severe pneumonia.
Primary outcome measures
- Comparing the diagnostic accuracy of AI-ROSE with traditional bronchoalveolar lavage fluid examination methods. [Time frame: 2026-3-31]
Eligibility criteria
Inclusion criteria
- Age 18 years and above
- The preliminary clinical diagnosis is a patient with lower respiratory tract infection
- Meets the criteria for severe pneumonia, which means one of the following conditions exists: ① Main criteria: septic shock requiring vasoactive drug support; Respiratory failure requiring mechanical ventilation; ② Secondary criteria: Meet at least 3 or more criteria, including respiratory rate>30 times/minute; Oxygenation index (PaO ₂/FiO ₂)<250; Multiple leaf segment infiltration; Consciousness disorders/orientation disorders; Urea nitrogen level>20mg/dL; White blood cell count<4 \* 10 \^ 9/L; platelet count<100 \* 10 \^ 9/L; core body temperature<36.8 ° C; hypotension requiring active fluid resuscitation
- The patient agrees to undergo bronchoscopy and bronchoalveolar lavage, and agrees to perform AI-ROSE testing on the bronchoalveolar lavage fluid
Exclusion criteria
- Patients with poor basic condition, severe illness, and inability to tolerate bronchoscopy examination
- The bronchoalveolar lavage fluid sample is not qualified
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Fluorescence Biological Microscope — Nanjing
Identifiers
NCT: NCT07113951 · 2025-SR-567