Delayed Tracheostoma Healing Following Decannulation in Long-term Tracheostomy PatientsSTOMA-PREDNCT07747844
Predictive Model for Stoma Healing After Tracheostomy Decannulation in Patients With Prolonged Tracheostomy
An observational study of Delayed Tracheostoma Healing Following Decannulation in Long-term Tracheostomy Patients, run by Capital Medical University at 1 site in China.
Trial summary
Prolonged tracheostomy is prone to induce chronic airway mucosal injury and tracheal cartilage degeneration, which not only elevates the risks of post-decannulation complications such as persistent fistula non-healing, airway stenosis and recurrent infections, but also impairs ventilatory, phonatory and deglutitive… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Delayed Tracheostoma Healing Following Decannulation in Long-term Tracheostomy Patients
- How many people
- 219 participants
- Where
- 1 siteChina
- Study dates
- 18 May 2026to 25 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with tracheostomy and decannulation in hospital
Who may be able to join
- Successful decannulation，it was defined as no need for tracheostomy tube reinsertion within 48 hours after decannulation
- Complete clinical data
- Voluntary participation in the study and signed informed consent form
Who cannot join
- Decannulation failure, with reinsertion of a tracheostomy tube or endotracheal tube
- Discharge from hospital before the tracheostomy stoma healed
- Refusal to participate in the study or withdrawal from the study midway
Trial locations and contacts
1 site in 1 country.
China1 site
Pulmonary Rehabilitation Center
Beijing, Beijing Municipality, 100114
About this study
Official title: Development and Validation of a Predictive Model for Stoma Healing After Decannulation in Patients With Prolonged Tracheostomy
Prolonged tracheostomy is prone to induce chronic airway mucosal injury and tracheal cartilage degeneration, which not only elevates the risks of post-decannulation complications such as persistent fistula non-healing, airway stenosis and recurrent infections, but also impairs ventilatory, phonatory and deglutitive functions, thereby exerting a severe adverse impact on patients' prognosis and quality of life.Accordingly, the retrospective observational study aimed to characterize stoma healing time after decannulation, identify key predictive factors, and develop and validate a clinically useful prediction model. These findings will offer evidence-based guidance for future researchers in selecting appropriate modeling methodologies and provide a scientific foundation for the development of targeted clinical intervention and prevention strategies.
Read the detailed description
Objective To develop and validate a predictive model for post-decannulation stoma healing in patients with prolonged tracheostomy, and screen high-risk predictors of poor wound healing.
Methods This retrospective observational study will recruit eligible patients and split subjects into training and validation cohorts at a fixed ratio.
Candidate clinical and stoma-related variables will be screened via LASSO regression. Multiple prediction models including logistic regression, decision tree and random forest will be built, and evaluated by AUC, Brier score and DCA.
Expected Outcomes Core predictive indicators linked to delayed stoma healing will be identified, and the optimal model with robust predictive performance will be determined to stratify patients into high-risk groups.
Expected Conclusions The optimal model can achieve accurate risk stratification for stoma healing disorders. Targeted interventions including personalized nutrition, standardized stoma care and activity management will be recommended for high-risk patients.
- Being tested
- No intervention
- Keywords
- Stoma healing after decannulation, tracheostomy, predictive model, rehabilitation patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No interventional measures were performed; patients were grouped according to natural stoma healing outcome.
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Complete Epithelial Closure of the Tracheostomy Stoma After Decannulation
Time to complete epithelial closure is defined as the number of days from tracheostomy tube decannulation to spontaneous complete epithelial closure of the tracheostomy stoma, as determined by clinical assessment. Participants who do not achieve complete epithelial closure within 30 days after decannulation will be censored at Day 30.
Measured: From the date of tracheostomy tube decannulation to the date of spontaneous complete epithelial closure of the tracheostomy stoma, assessed up to 30 days after decannulation
Secondary outcomes (1)
Correlates of delayed tracheostomy stoma healing after decannulation
Baseline demographic characteristics, laboratory parameters, rehabilitation-related variables, and tracheostomy-related clinical indicators will be collected at the pre-decannulation baseline assessment. Delayed tracheostomy stoma healing is defined based on the time (in days) to spontaneous complete epithelial closure of the tracheostomy stoma after decannulation, assessed via routine clinical wound visual inspection. Machine learning algorithms will be applied to screen candidate predictive variables and quantify the relative predictive contribution of each baseline variable to the time to complete stoma epithelial closure.
Measured: Pre-decannulation baseline assessment through confirmation of complete epithelial closure of the tracheostomy stoma; all assessments will be completed within 30 days after decannulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start18 May 2026
- Primary completion18 Jun 2026
- Study completion25 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Tracheostoma Healing Following Decannulation in Long-term Tracheostomy PatientsStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongying Jiang, MD, Capital Medical University
- Investigators
- Hongying Jiang, MD, Study chair, Pulmonary Rehabilitation Center, Beijing Rehabilitation Hospital of Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747844
- Sponsor's protocol ID
- 2026-LK
- Other IDs
- 2026bkky-061
- Acronym
- STOMA-PRED
- Status last verified
- Aug 2026
- First submitted
- 5 Jun 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Predictive Model for Stoma Healing After Decannulation in Patients With Prolonged Tracheostomy
- ClinicalTrials.gov ID
- NCT07747844
- Acronym / sponsor ID
- STOMA-PRED / 2026-LK
- Keywords
- Stoma healing after decannulation, tracheostomy, predictive model, rehabilitation patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 18 May 2026 (actual)
- Primary completion
- 18 Jun 2026 (actual)
- Study completion
- 25 Jun 2026 (actual)
- First posted
- 5 Aug 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.
Prolonged tracheostomy is prone to induce chronic airway mucosal injury and tracheal cartilage degeneration, which not only elevates the risks of post-decannulation complications such as persistent fistula non-healing, airway stenosis and recurrent infections, but also impairs ventilatory, phonatory and deglutitive functions, thereby exerting a severe adverse impact on patients' prognosis and quality of life.Accordingly, the retrospective observational study aimed to characterize stoma healing time after decannulation, identify key predictive factors, and develop and validate a clinically useful prediction model. These findings will offer evidence-based guidance for future researchers in selecting appropriate modeling methodologies and provide a scientific foundation for the development of targeted clinical intervention and prevention strategies.
Detailed description
Objective To develop and validate a predictive model for post-decannulation stoma healing in patients with prolonged tracheostomy, and screen high-risk predictors of poor wound healing.
Methods This retrospective observational study will recruit eligible patients and split subjects into training and validation cohorts at a fixed ratio.
Candidate clinical and stoma-related variables will be screened via LASSO regression. Multiple prediction models including logistic regression, decision tree and random forest will be built, and evaluated by AUC, Brier score and DCA.
Expected Outcomes Core predictive indicators linked to delayed stoma healing will be identified, and the optimal model with robust predictive performance will be determined to stratify patients into high-risk groups.
Expected Conclusions The optimal model can achieve accurate risk stratification for stoma healing disorders. Targeted interventions including personalized nutrition, standardized stoma care and activity management will be recommended for high-risk patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with tracheostomy and decannulation in hospital
Key inclusion criteria (3 listed)
- Successful decannulation，it was defined as no need for tracheostomy tube reinsertion within 48 hours after decannulation
- Complete clinical data
- Voluntary participation in the study and signed informed consent form
Key exclusion criteria (3 listed)
- Decannulation failure, with reinsertion of a tracheostomy tube or endotracheal tube
- Discharge from hospital before the tracheostomy stoma healed
- Refusal to participate in the study or withdrawal from the study midway
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 |
|---|---|---|
| No interventionNo interventional measures were performed; patients were grouped according to natural stoma healing outcome. | Other | – |
Primary outcome
Time to Complete Epithelial Closure of the Tracheostomy Stoma After Decannulation
Time frame: From the date of tracheostomy tube decannulation to the date of spontaneous complete epithelial closure of the tracheostomy stoma, assessed up to 30 days after decannulation
Time to complete epithelial closure is defined as the number of days from tracheostomy tube decannulation to spontaneous complete epithelial closure of the tracheostomy stoma, as determined by clinical assessment. Participants who do not achieve complete epithelial closure within 30 days after decannulation will be censored at Day 30.
1 secondary outcome
Correlates of delayed tracheostomy stoma healing after decannulation
Time frame: Pre-decannulation baseline assessment through confirmation of complete epithelial closure of the tracheostomy stoma; all assessments will be completed within 30 days after decannulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 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. This study is not recruiting at the moment.
Hongying Jiang, MD study chair
Pulmonary Rehabilitation Center, Beijing Rehabilitation Hospital of Capital Medical University
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 Delayed Tracheostoma Healing Following Decannulation in Long-term Tracheostomy Patients, run by Capital Medical University 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 5 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Complete Epithelial Closure of the Tracheostomy Stoma After Decannulation (time frame: From the date of tracheostomy tube decannulation to the date of spontaneous complete epithelial closure of the tracheostomy stoma, assessed up to 30 days after decannulation). 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 5 Aug 2026.