Construction and Effect Evaluation of Integrated Care Model for Pulmonary Infection in Stroke Patients With Tracheotomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Clinical Pulmonary Infection Score
研究概览
简要总结
- To understand the occurrence of pulmonary infection in stroke patients with tracheotomy, and to clarify the current situation of clinical nursing.
- Construct a standardized, systematic and scientific integrated care model to control the severity of pulmonary infection in non-acute stroke patients with simple tracheotomy.
- To evaluate the clinical application effect of integrated care model of pulmonary infection in stroke patients with tracheotomy.
详细描述
1. Research content This study involves two parts: construction and effect evaluation.
- The construction link includes: retrospective analysis of patient data, clinical observation, literature review, expert consultation, and pre-experiment.
- Effect evaluation: The integrated care model was applied to the clinic, and the patients' CPIS score, Beck oral score, ZBI caregiver burden score, EQ-5D score and hospitalization cost were collected to evaluate the effect of the model.
2. The grouping method Convenience sampling method was used to select patients with simple tracheotomy for non-acute stroke who were admitted to the Department of Rehabilitation Medicine of Shenzhen Second People's Hospital as the research object, and the patients before the implementation of the integrated care model(May-July 2022) were set as the control group , the patients after the implementation of the integrated care model (August-October 2022) were set as the intervention group.
3. Sample Size Estimation
- This study is a quasi-experimental study, and the main outcome indicator is the control of pulmonary infection (CPIS score). Therefore, the sample size estimation method of the group design quantitative data sample mean is adopted.
- Based on the results reported in similar research literature, the authors assumed that the CPIS scores of the control group and the intervention group were 3.9±1.5 and 2.8±1.1, respectively. Set β=0.1, power (Power=1-β)=90%, two-sided α=0.05 at the significance level, and the sample size of each group was 32 cases after calculation by G-power3.1 software. According to the 20% dropout rate, the final sample size of each group was 40 cases, and there were 80 cases in the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-acute stroke patients diagnosed by MRI or CT who meet the diagnostic criteria of the "Chinese Guidelines for the Prevention and Treatment of Cerebrovascular Diseases";
- •Those who meet the diagnostic criteria for pulmonary infection;
- •Age ≥18 years old;
- •Tracheotomy patients who have been off the ventilator or do not need mechanical ventilation;
- •Patients who can cooperate with the research and sign the informed consent.
排除标准
- •Patients whose vital signs are unstable and may be transferred to ICU for treatment in the future;
- •Patients with malignant tumors or other infectious diseases.
研究组 & 干预措施
control group
Implement routine nursing such as: routine oral nursing, tracheostomy, dressing change, sputum suction nursing, oral education, etc.
intervention group
Implement comprehensive nursing models such as: admission risk assessment, personalized oral care based on beck oral score, aspiration prevention, airway care, diversified health education
干预措施: integrated care model (Other)
结局指标
主要结局
Clinical Pulmonary Infection Score
时间窗: 3 weeks after admission
The scale mainly includes 7 indicators of body temperature, white blood cell count, tracheal secretions, oxygenation, chest X-ray, progress of pulmonary exudation, and microbial culture of tracheal aspirates, each with 0 to 2 points, with a total score of 12 If the score is less than 6, the lung infection is considered to be controlled.
Clinical Pulmonary Infection Score
时间窗: Within 1 week of admission
The scale mainly includes 7 indicators of body temperature, white blood cell count, tracheal secretions, oxygenation, chest X-ray, progress of pulmonary exudation, and microbial culture of tracheal aspirates, each with 0 to 2 points, with a total score of 12 If the score is less than 6, the lung infection is considered to be controlled.
次要结局
- Zarit Caregiver Burden Interview, ZBI(3 weeks after admission)
- EuroQol-5 Dimension， EQ-5D(3 weeks after admission)
- Beck Oral Assessment Score(BOAS)，modified(3 weeks after admission)
- Beck Oral Assessment Score(BOAS)，modified(Within 1 week of admission)
- Zarit Caregiver Burden Interview, ZBI(Within 1 week of admission)
- EuroQol-5 Dimension， EQ-5D(Within 1 week of admission)