跳至主要内容
临床试验/NCT02253706
NCT02253706Unknown不适用

Oxygen Supplementation During Bronchoscopy: High-Flow Nasal Cannula or Low-Flow Nasal Cannula

Shaare Zedek Medical Center2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
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

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Oxygen Supplementation During Bronchoscopy: High... | 临床试验