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NCT07901946

Laryngotracheal Lesions in Adults With Long-Term Tracheostomy

Sponsor: Hongying Jiang, MD

View on ClinicalTrials.gov

Summary

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.

Official title: Spectrum of Laryngotracheal Lesions and Associated Risk Factors in Adults With Long-Term Tracheostomy: A Multicenter Prospective Observational Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

220

Start Date

2026-12-01

Completion Date

2027-10-31

Last Updated

2026-10-28

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Standardized Three-Station Bronchoscopy

Standardized bronchoscopy through the tracheostomy tube and transnasally to assess the larynx, subglottic region, suprastomal trachea, stoma region, and distal trachea. The examination is not assigned as a treatment and is not intended to compare treatment effects.

Locations (1)

Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China

Beijing, Beijing Municipality, China