Predictive Model for Stoma Healing After Tracheostomy Decannulation in Patients With Prolonged Tracheostomy

NCT07747844 | Completed DMC

• 2 other identifiers: 2026-LK2026bkky-061
• Study Type: observational
• Target: 219
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Delayed Tracheostoma Healing Following Decannulation in Long-term Tracheostomy Patients

Keywords

Stoma healing after decannulation; tracheostomy; predictive model; rehabilitation patients

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Pre-decannulation baseline assessment through confirmation of complete epithelial closure of the tracheostomy stoma; all assessments will be completed within 30 days after decannulation

Interventions

No intervention OTHER

No interventional measures were performed; patients were grouped according to natural stoma healing outcome.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with tracheostomy and decannulation in hospital

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Pulmonary Rehabilitation Center

Beijing, Beijing Municipality, 100114, China

Location

Study Officials

• Hongying Jiang, MD

  Pulmonary Rehabilitation Center, Beijing Rehabilitation Hospital of Capital Medical University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Director

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: August 5, 2026
• Study Start: May 18, 2026
• Primary Completion: June 18, 2026
• Study Completion: June 25, 2026
• Last Updated: August 5, 2026

Record last verified: 2026-08

Locations

CN (1)