Study on Influencing Factors and Intervention of Silent Aspiration After Heart Valve Operation in Elderly Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- α-Amylase Level in Airway Secretions
研究概览
简要总结
Objective To investigate the safety and effectiveness of interference electrical stimulation in the prevention of silent aspiration after heart valve surgery in elderly patients. Silent aspiration was diagnosed when either pepsin level >200 ng/ml or α-amylase level >1685 U/L was detected in airway secretions.
详细描述
In this study, a randomized controlled trial was conducted in elderly patients undergoing heart valve surgery at Fujian Medical University Union Hospital. Patients were selected according to the inclusion and exclusion criteria and randomly allocated to either the experimental group (routine nursing + interference electrical stimulation) or the control group (routine nursing + blank stimulation). Silent aspiration was diagnosed when either pepsin level >200 ng/ml or α-amylase level >1685 U/L was detected in airway secretions. Airway secretions were collected upon ICU admission after surgery, every 12 hours thereafter (depending on endotracheal tube indwelling time), before extubation, 24 hours after extubation, and on day 6 after surgery. The incidence of silent aspiration, swallowing function, clinical pulmonary infection score, mechanical ventilation duration, ICU length of stay, total hospital stay, and adverse events were compared between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Simple valve surgery
- •Age ≥60 years old
- •NYHA cardiac function Grade II-III
- •ASA Grade II-III
- •No dysphagia screened by SSA before surgery
排除标准
- •Vocal cord dysfunction, oropharyngeal malignancies, or neck surgery affecting swallowing function
- •Postoperative hemodynamic instability and active bleeding
- •COPD, asthma, chronic bronchitis, lung cancer or other respiratory diseases
- •Previous gastroesophageal reflux disease
- •Serious mental or neurological disease
- •Skin damage or electrode allergy at the stimulation site
- •Implanted cardiac pacemaker
- •Participation in other interventional studies
结局指标
主要结局
α-Amylase Level in Airway Secretions
时间窗: Upon admission to ICU after surgery, every 12 hours thereafter (depending on endotracheal catheter indwelling time), before extubation, 24 hours after extubation, 6 days after surgery.
α-Amylase level in airway secretions was measured as a biomarker for silent aspiration. A level \>1685 U/L was considered positive for silent aspiration.
Pepsin Level in Airway Secretions
时间窗: Upon admission to ICU after surgery, every 12 hours thereafter (depending on endotracheal catheter indwelling time), before extubation, 24 hours after extubation, 6 days after surgery.
Pepsin level in airway secretions was measured as a biomarker for silent aspiration. A level \>200 ng/ml was considered positive for silent aspiration.
次要结局
- Mechanical Ventilation Duration(During the ICU stay, assessed at the time of extubation.)