Oxygen Supplementation During Bronchoscopy: High-Flow Nasal Cannula or Low-Flow Nasal Cannula
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Oxygen desaturation index 4% (ODI4%)
研究概览
简要总结
In general bronchoscopy is a safe procedure with low rate of complications. Indeed, contraindications to flexible bronchoscopy are mostly relative rather than absolute. This is the case of preexisting decreased blood oxygen levels which may be present in patients requiring further bronchopulmonary investigation. To avoid the deleterious effects of oxygen drops oxygen supplementation is recommended.
The purpose of this study is to evaluate the efficiency and safety of oxygen supplementation obtained with the use of a high flow nasal cannula compared with a low flow nasal cannula during flexible bronchoscopy.
Consecutive patients referred by their treating physician for bronchoscopy will be offered to take part in the study. Those who wish to participate and give their consent will be randomly assigned into one of two treatment groups (supplemental oxygen given via low flow nasal cannula or via high flow nasal cannula).
Assignment to either treatment arm will not affect in any way the intended purpose of the bronchoscopy. All patients will be closely monitored during the procedure and 2 hours following its completion. Monitoring will be conducted, using strictly non-invasive measures.
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
- None
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
- •patients scheduled to undergo routine bronchoscopy for diagnostic purposes
排除标准
- •inability to give an informed consent
- •nasal deformities
研究组 & 干预措施
Low flow nasal oxygen supplementation
Low flow nasal oxygen supplementation as per routine standard of care(control arm)
干预措施: low flow nasal oxygen supplementation (Device)
High flow nasal oxygen supplementation
High-flow nasal ventilation: This will be carried out using the Precision Flow device (Opti-Flow, Auckland, New Zealand). This device is intended to add warm moisture to breathing gases from an external source. Flow rate via the nasal cannula will be kept at 50 Liters/min and fractional inspired oxygen concentration will be set at 0.35
干预措施: High flow nasal oxygen supplementation (Device)
结局指标
主要结局
Oxygen desaturation index 4% (ODI4%)
时间窗: duration of bronchoscopy with an expected average duration of 30 minutes
oxygen cumulative time below 88%(OCT88%)
时间窗: beginning to end of bronchoscopy procedure with an expected average duration of 30minutes
次要结局
- number of bradycardic and tachycardic events(beginning to end of bronchoscopy with an expected averag duration of 30 minutes)
- change in expired end tidal carbon dioxide before and after completion of bronchoscopy(beginning to end of bronchoscopy with an expected average duration of 30 minutes)
- oxygen desaturation index 4%(preprocedural to 2 hours post procedure with an expected total duration of 3 hours)
- cumulative oxygen time 88%(pre-procedural to 2 hours post precedure with an expected total duration of 3 hours)