Impact of Interventional Endoscopy on Quality of Life in Patients With Acute Respiratory Distress Due to Tumor Compression or Obstruction of the Lower Respiratory Tract
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Saint George Score (quality of life)
研究概览
简要总结
Bronchoscopic endoscopy has shown its effectiveness and reliability for the treatment (desobstruction or prothesis) of tumor-induced bronchial obstructions, particularly in the first few weeks. The presence of a lower airway prosthesis can lead to device obstruction requiring daily inhaled fluidification, bacterial colonization, migration of the prosthesis, or the appearance of obstructive or hemorrhagic granulomas.
The aim of this study is to evaluate the quality of life of patients after endobronchial treatment.
It is a prospective, descriptive, and multicentric (national) study. The main objective is to compare the total score on the Saint-George questionnaire at J7 of the interventional endoscopy compared to before the procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years old
- •tumoral tracheobronchial obstruction and/or compression
- •proven solid cancer or suspicion
- •Acute respiratory distress (at least one of the 5):
- •RR : ≥25/min
- •Sign of respiratory struggle
- •Sign of respiratory failure
- •Oxygen therapy ≥5L/min
- •Ventilatory support (NIV, OHD or IT) :
- •Indication for therapeutic interventional endoscopy
- •No guardianship or curatorship
- •Non-hematological tumor
排除标准
- •patients with neurological disabilities unable to understand and respond to the questionnaire
- •patients under guardianship or curatorship
结局指标
主要结局
Saint George Score (quality of life)
时间窗: At inclusion, and 7 days after therapeutic bronchoscopy
Difference between Saint-George score at inclusion and Day 7. The scores for each dimension range from 0 to 100, with a score of 100 indicating excellent health.
次要结局
- anti-tumoral treatment(During the 30 first days from intervention)
- survival(through study completion, an average of 1 year)
- ECOG-performance Status(inclusion and Day 30)
- Duration of ventilatory support (mechanical ventilation, non-invasive ventilation, high-flow oxygen)(During the 30 first days from intervention)
- Saint-George and SF-12 (12-Item Short-Form Health Survey) score(at inclusion and Day 30)
- hospitalization duration(During the 30 first days from intervention)