Laryngotracheal LesionsNCT07901946
Laryngotracheal Lesions in Adults With Long-Term Tracheostomy
An observational study of Laryngotracheal Lesions and Tracheostomy Complications, run by Hongying Jiang, MD at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngotracheal Lesions, Tracheostomy Complications, Tracheal Stenosis
- What is being tested?
- Standardized Three-Station Bronchoscopy
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2026to 31 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Rehabilitation Hospital, Capital Medical University, Beijing,China
Beijing, Beijing Municipality, 100043
About this study
Official title: Spectrum of Laryngotracheal Lesions and Associated Risk Factors in Adults With Long-Term Tracheostomy: A Multicenter Prospective Observational Study
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.
Read the detailed description
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.
- Conditions
- Laryngotracheal Lesions, Tracheostomy Complications, Tracheal Stenosis, Tracheomalacia, Vocal Cord Paralysis
- Being tested
- Standardized Three-Station Bronchoscopy
- Medical subject headings
- Tracheal Stenosis, Tracheomalacia, Vocal Cord Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Three-Station BronchoscopyDiagnostic test
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 group | Role | What they receive |
|---|---|---|
| Adults with long-term tracheostomy | 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. Receives: Diagnostic Test: Standardized Three-Station Bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 1 week after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngotracheal LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hongying Jiang, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hongying Jiang, MD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07901946
- Sponsor's protocol ID
- BK-dxz-LL
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectrum of Laryngotracheal Lesions and Associated Risk Factors in Adults With Long-Term Tracheostomy: A Multicenter Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07901946
- Acronym / sponsor ID
- BK-dxz-LL
- Conditions
- Laryngotracheal Lesions, Tracheostomy Complications, Tracheal Stenosis, Tracheomalacia, Vocal Cord Paralysis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Hongying Jiang, MDUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with long-term tracheostomy | – | Diagnostic Test: Standardized Three-Station BronchoscopyAdults 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized Three-Station BronchoscopyStandardized 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. | Diagnostic test | Adults with long-term tracheostomy |
Primary outcome
Prevalence of Any Laryngotracheal Lesion
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laryngotracheal Lesions and Tracheostomy Complications, run by Hongying Jiang, MD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingyi Ge (+861056981098, ge_jingyi2020@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Any Laryngotracheal Lesion (time frame: Within 1 week after enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.