An observational study in Laryngotracheal Lesions, Tracheostomy Complications and Tracheal Stenosis, sponsored by Hongying Jiang, MD. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Hongying Jiang, MD · Observational
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.
The study is a multicenter, prospective, observational cohort study of adults with a tracheostomy tube in place for at least 14 days. The planned sample size is 224 participants. Participants will be recruited from respiratory rehabilitation centers that have appropriate bronchoscopy and airway-emergency facilities and trained operators.
Baseline information will include demographics, smoking history, body mass index, primary disease, nutritional and disease-severity scores, laboratory results, nasogastric tube use, prior oral endotracheal intubation, indication and technique of tracheostomy, tracheostomy site, tube type and size, cuff-management practices, humidification, duration of mechanical ventilation, and corticosteroid and proton-pump-inhibitor use.
Within 1 week after enrollment, participants will undergo a standardized three-station bronchoscopy. The first station will assess the tracheal wall at the level of the distal tracheostomy tube. The second station will assess the pharynx and larynx, including vocal cord movement during brief tube occlusion. The third station will assess the subglottic area, suprastomal trachea, stoma region, and tracheal collapse after temporary tube removal and stoma occlusion, followed by immediate tube replacement. Procedures will be performed under topical anesthesia with continuous cardiorespiratory monitoring and video recording. Adverse events and serious adverse events related to the examination will be recorded according to the approved protocol.
The primary analysis will describe the prevalence of predefined laryngotracheal lesions. Multivariable logistic regression, with adjustment for center clustering when appropriate, will be used to explore factors associated with prespecified lesions. This is an observational study; no participant will be prospectively assigned to a treatment or exposure group.
42 studies on the registry are indexed under Tracheal Stenosis; 11 are open to participants now.
This study's planned enrollment of 220 is above the median of 76 across 15 observational studies indexed under Tracheal Stenosis.
Browse Tracheal Stenosis studies →Hongying Jiang, MD is the lead sponsor of 8 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults receiving care at participating respiratory rehabilitation centers in China who have a tracheostomy tube in place for at least 14 days and are clinically stable enough to undergo the standardized bronchoscopy assessment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults with a tracheostomy tube in place for at least 14 days who meet the eligibility criteria and undergo the standardized three-station bronchoscopy. The study does not assign participants to different treatment groups. Prespecified exposures and clinical characteristics will be evaluated within this single cohort.
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.
Prevalence of Any Laryngotracheal Lesion
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.
Time frame: Within 1 week after enrollment.
Start is estimated for Dec 2026; primary completion for Sep 2027, 9 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hongying Jiang, MD