Laryngotracheal Lesions in Adults With Long-Term Tracheostomy

This multicenter prospective observational cohort study will enroll 224 adults with a tracheostomy tube in place for at least 14 days. Within 1 week after enrollment, each participant will undergo a standardized three-station bronchoscopy through the tracheostomy tube and transnasally, with temporary tube occlusion and immediate tube replacement when required. The study will describe the prevalence, anatomic distribution, and severity of laryngotracheal lesions, including mucosal ulceration, scar formation, granulation tissue, vocal cord paralysis, subglottic stenosis, and tracheomalacia. The study will also evaluate clinical and tracheostomy-related factors associated with these lesions. No treatment is assigned by the study; the bronchoscopy is a standardized diagnostic assessment performed for research evaluation.

Inclusion Criteria: * Age 18 years or older. * Tracheostomy tube in place for at least 14 days. * Clinically stable and able to tolerate transnasal and trans-tracheostomy bronchoscopy according to the prespecified pre-procedure assessment. * Written informed consent provided by the participant or the legally authorized representative, as applicable. Exclusion Criteria: * Permanent tracheostomy, including status after total laryngectomy, irreversible upper-airway obstruction, or a clinical plan for lifelong tracheostomy. * History of head and neck malignancy or prior head and neck radiotherapy. * Airway stenosis caused by a primary airway disease, including tracheobronchial tuberculosis, relapsing polychondritis, granulomatosis with polyangiitis, tracheobronchial amyloidosis, or congenital airway malformation. * Laryngotracheal stenosis diagnosed before tracheostomy. * Contraindication to bronchoscopy or inability to tolerate brief tube-occlusion observation. * Expected survival of less than 1 month. * Refusal to participate or inability to obtain informed consent.