Diagnostic Application of AI-ROSE in Severe Pneumonia

Diagnostic Application of Microbiological Fluorescence Rapid On-site Evaluation Combined With Artificial Intelligence in Severe Pneumonia: a Multi-center Prospective Study

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07113951

Enrollment

100

Registered

2025-08-11

Start date

2025-08-31

Completion date

2026-12-31

Last updated

2025-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Infections, Severe Pneumonia

Keywords

Severe Pneumonia, artificial intelligence, Rapid on-site evaluation, Diagnosis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

China

Outcome results