Diagnostic Application of AI-ROSE in Severe Pneumonia

• Conditions: Severe Pneumonia; Bacterial Infections

• Registration Number: NCT07113951
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-08-03
• Study First Submitted QC: 2025-08-03
• Last Update Submitted: 2025-08-03
• Study First Posted: 2025-08-11
• Last Update Posted: 2025-08-11
• Study Start: 2025-08-31
• Primary Completion: 2026-08-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparing the diagnostic accuracy of AI-ROSE with traditional bronchoalveolar lavage fluid examination methods.	2026-3-31

Trial Locations

Locations (1)

Fluorescence Biological Microscope; 🇨🇳 Nanjing, Jiangsu, China