FBS-ASaP: Fibrobronchoscopy in ASpiration Pneumonia in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mortality rate within 30 days from the time of admission to the Emergency Department
研究概览
简要总结
Non-Profit Prospective Observational Pilot Study
The study will have an overall duration of 3 years, with patient enrollment starting after ethical committee approval.
In this study, all patients with a diagnosis of aspiration pneumonia who require aspiration of secretions or ingesta in the Emergency Department will be considered. A registry will be created with the patients' data, noting the type of procedure performed: laryngotracheal aspiration with a probe or with fibrobronchoscopy.
This observational registry pilot study aims to evaluate the utility and adverse events related to the use of aspiration via videobronchoscopy performed in the Emergency Department and to compare the clinical outcomes of patients undergoing bronchoscopy with those treated only with blind laryngotracheal aspiration using a probe.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult patients who access the Emergency Department with a diagnosis of aspiration pneumonia and for whom the referring physician determines the need for aspiration of secretions or ingesta. Patients must have at least one of the following criteria
- •Radiological evidence of pneumonia (Chest X-ray/CT scan/Chest ultrasound)
- •Clinical diagnosis of aspiration pneumonia
- •Presence of secretions in the upper airways
- •Respiratory distress in a dysphagic patient
- •Need for oxygen therapy or need to increase FiO2 in patients already on home oxygen therapy
排除标准
- •Lack of consent
- •Age < 18 years
- •Pregnancy
- •Hemorrhagic diathesis
- •Malignant cardiac arrhythmias (VT, AV block excluding first-degree AV block)
- •Severe airway obstruction
结局指标
主要结局
Mortality rate within 30 days from the time of admission to the Emergency Department
时间窗: 30 days from admission to the ed
Mortality rate within 30 days from the time of admission to the Emergency Department
Length of hospital stay in days
时间窗: up to 3 months
Length of hospital stay in days
次要结局
- Respiratory parameters before and after the procedure(on the admission and 30 minutes after the procedure)
- Rate of patient treated with Non invase ventilation and with orotracheal intubation(on the admission and 30 minutes after the procedure)
- Rate of admission in Intensive care unit and High dependency unit(immediately after the procedure)
- Procedure-related complications(perioperatively/periprocedurally)
研究者
Peiman Nazerian
Principal Investigator
Azienda Ospedaliero-Universitaria Careggi