Practice of Oxygenation and Respiratory Support During Fiberoptic Bronchoscopy: the Oxy-FOB STUDY
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Type of oxygenation strategy adopted
研究概览
简要总结
The current practice of oxygenation and/or ventilation supports in patients undergoing Fiberoptic Bronchoscopy is very heterogeneous among studies published in the literature; in addition, clear outcomes advantages of one strategy over another currently lack.
The goal of this observational study is to describe the current practice of oxygenation and/or ventilation supports in patients undergoing Fiberoptic Bronchoscopy (FOB), stratified by baseline respiratory condition, co-morbidities, type of procedure and hospital settings.
Investigators will enroll all adult patients undergoing any fiberoptic bronchoscopy in any clinical settings (from outpatients to critically ill patients). No specific exclusion criteria are indicated for enrollment in this study.
Investigators will record the following data:
- Patient's baseline data.
- Type of FOB procedure: toilet bronchoscopy (for secretions, blood, mucus plugs removal), broncho-aspirate (BAS), bronchoalveolar lavage (BAL), brushing for cytology, biopsy, endobronchial ultrasound (EBUS). The type and size of bronchoscope (with or without an internal/external camera) and the time of the procedure will be also recorded.
- Type of supportive strategy: no support, Standard Oxygen Therapy, High Flow Nasal Cannula, Continuous Positive Airway Pressure and or non invasive ventilation trough mask or helmet, invasive mechanical ventilation.
- Sedation
- Intra-procedural vital parameters
- Occurrence of adverse events: desaturation (i.e. SpO2< 90% for at least 10 seconds), severe desaturation (i.e. SpO2< 80%), need for procedure interruption, hypotensive (systolic blood pressure <90 mmHg) or hypertensive (systolic blood pressure >140 mmHg) events, new onset of cardiac arrhythmias (specify the rhythm) or myocardial ischemia or electrocardiographic ST-alterations, neurological events (i.e. severe sensorium depression, psychomotor agitation).
- Post-procedural vital parameters (15 minutes after the procedure).
- Clinical outcomes: need for support escalation, need for admission to ward (for outpatient) or ICU (for outpatients and ward-admitted patient).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Need for any procedure with flexible FOB
- •Either outpatients in dedicated ambulatories, and admitted to any hospital ward or Intensive Care Unit (ICU)
排除标准
- 未提供
结局指标
主要结局
Type of oxygenation strategy adopted
时间窗: Through the endoscopy completion, an average of 30 minutes
The type of oxygenation strategy (standard oxygen therapy, high flow nasal cannula, continuous positive airway pressure, non invasive ventilation or invasive mechanical ventilation) adopted during the bronchoscopy will be recorded.
次要结局
- Lowest heart rate(Through the endoscopy completion, an average of 30 minutes)
- Duration of the procedure(From the beginning to the end of the endoscopy procedure)
- Desaturation events(Through the endoscopy completion, an average of 30 minutes)
- Admission to ward or intensive care unit(At the end of the endoscopy completion, after an average of 30 minutes from study start)
- Type of sedation strategy adopted(Through the endoscopy completion, an average of 30 minutes)
- Lowest peripheral oxygen saturation(Through the endoscopy completion, an average of 30 minutes)
- Lowest systolic blood pressure(Through the endoscopy completion, an average of 30 minutes)
- Hypertensive events(Through the endoscopy completion, an average of 30 minutes)
- Severe desaturation events(Through the endoscopy completion, an average of 30 minutes)
- Highest heart rate(Through the endoscopy completion, an average of 30 minutes)
- Highest systolic blood pressure(Through the endoscopy completion, an average of 30 minutes)
- Hypotensive events(Through the endoscopy completion, an average of 30 minutes)
- Need for support escalation(Through the endoscopy completion, an average of 30 minutes)
研究者
Federico Longhini
Director of the Intensive Care and Anesthesia Department
University Magna Graecia