Development and Validation of a Predictive Model for Stoma Healing After Decannulation in Patients With Prolonged Tracheostomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 219
- 试验地点
- 1
- 主要终点
- Time to Complete Epithelial Closure of the Tracheostomy Stoma After Decannulation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Time to Complete Epithelial Closure of the Tracheostomy Stoma After Decannulation
时间窗: 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.
次要结局
- 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)
研究者
Hongying Jiang, MD
Department Director
Capital Medical University