AI-Assisted Bronchoscopy Navigation and Diagnostic System for Severe Pneumonia: A Multicenter Prospective Study

Rationale: Severe pneumonia often requires bronchoscopy for diagnosis and therapy, yet accurate segmental localization and consistent interpretation are operator-dependent and time-consuming. Prior work by the sponsor team integrated CT-based planning with real-time bronchoscopic guidance and AI-based lesion characterization. The investigational system overlays guidance and voice prompts during bronchoscopy to standardize navigation and reduce errors.

Design: Prospective multicenter controlled study in ICUs/respiratory units. Approximately 100 adults undergoing clinically indicated bronchoscopy for severe pneumonia will be enrolled across ~10 centers in China. Procedures will be performed either with AI assistance or with standard bronchoscopy per site workflow. Outcomes include: (1) diagnostic agreement versus a predefined reference (primary); (2) navigation success/loss-of-path; (3) procedure time; and (4) adverse events (e.g., bleeding, hypoxemia, infection). Enrollment is planned to start in Sep 2025, with anticipated primary completion around Sep 2026.

Operations: Data will be collected using a standardized CRF and analyzed per a prespecified SAP. The investigational software is integrated with an endoscopic image processor developed with an industry partner; physicians can follow or ignore AI suggestions at their discretion. The study will generate evidence on effectiveness and safety to inform subsequent registration testing and scaling.

Inclusion criteria

• Age ≥18 years.
• Severe pneumonia requiring clinically indicated bronchoscopy for diagnosis and/or therapy, as determined by the treating team.
• Written informed consent from the patient or a legally authorized representative.
• Expected to tolerate bronchoscopy with current respiratory support (e.g., HFNC/NIV/IMV) per site protocol

Exclusion criteria

• Standard contraindications to bronchoscopy, such as uncontrolled hypoxemia despite support (SpO2 <90% for ≥30 s on FiO2 ≥0.60), hemodynamic instability requiring escalating vasopressors, or malignant arrhythmia not controlled.
• Uncorrected coagulopathy likely to increase bleeding risk (e.g., platelets <50×10^9/L or INR >1.5) per site policy.
• Known pregnancy or breastfeeding if the investigator judges risk outweighs benefit according to site policy.
• Participation in another interventional drug/device study that could interfere with outcomes.
• Any condition that, in the investigator's judgment, makes participation unsuitable (e.g., emergent life-saving bronchoscopy without time for consent).