Diagnostic Application of AI-ROSE in Severe Pneumonia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-31

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of a COVID-19 Pneumonia CXR AI Detection Algorithm

NCT04561024

Covid19

UNKNOWN

Lung Ultrasound in Comparison With C.T in Covid-19

NCT05158803

COVID-19

UNKNOWN

An Artificial Intelligence System for ROSE of EUS-FNA Sample: a Prospective, Multicenter, Diagnostic Study.

NCT06718725

The Malignant Lesions and Non-malignant Lesions of Pancreas, Bile Duct, Liver and Lymph Node

RECRUITING

Radiomics Model for the Diagnosis of Pneumocystis Jirovecii Pneumonia in Non-HIV Patients

NCT05701631

Pneumocystis Jirovecii Pneumonia

UNKNOWN

Clinical Evaluation of ASP Health's Automated ROSE System for Bronchoscopic Applications

NCT05120050

Lung Diseases Lung Cancer

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Severe Pneumonia Bacterial Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes