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Clinical Trials in China / NCT07901946
Starting soon Observational

Laryngotracheal Lesions in Adults With Long-Term Tracheostomy

NCT07901946 · tracked via the Priya Life Science China tracker
Sponsor
Hongying Jiang, MD
Phase
Observational
Started
2026-12-01
Last updated
2026-10-28

Condition(s) studied

Laryngotracheal LesionsTracheostomy ComplicationsTracheal StenosisTracheomalaciaVocal Cord Paralysis

Investigational drug(s) / intervention(s)

Standardized Three-Station Bronchoscopy

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Prevalence of Any Laryngotracheal Lesion — Within 1 week after enrollment.
    Proportion of enrolled participants with at least one predefined laryngotracheal lesion detected by standardized three-station bronchoscopy, including mucosal ulceration, scar formation, granulation tissue, vocal cord paralysis, subglottic stenosis, tracheomalacia, or other prespecified structural or functional lesion. The estimate will be reported with a 95% confidence interval.

Trial sites (1)

FacilityCityRegionStatus
Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China Beijing Beijing Municipality

More Hongying Jiang, MD trials in China

A Speaking-Valve-Based Decannulation Protoco for Patients With a Prolonged Disorders of Consciousness Enrolling by invitation
Cough Flow as a Criterion Decannulation Threshold in Prolonged Tracheostomy Patients Starting soon
Integrated Rehabilitation in HDU for Post-Intensive Care SyndromeLiberation in Patients With PICS Starting soon
Speaking Valve Trial vs. Capping Trial for Tracheostomy Decannulation in Prolonged Disorders of Consciousness Enrolling by invitation
Comparison of Speaking Valve Trial and Capping Trial for Tracheostomy Decannulation in Stroke Patients Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07901946 on ClinicalTrials.gov ↗ ← All trials in China