Phase II Randomised Study of Nasal Oxygen Treatment for Pain Relief During Percutaneous Coronary Interventions
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Chest pain measured with VAS
研究概览
简要总结
Nasal oxygen is widely used as pain relief against ischemic pain during Percutaneous Coronary Intervention (PCI). However, to our knowledge no randomised clinical trials have tested this. In contrast, oxygen causes coronary artery vasoconstriction in man. Furthermore, a recent Cochrane meta-analysis has shown no evidence of beneficial effect of oxygen for patients with acute myocardial infarction (with normal blood saturation. The investigators therefore wanted to examine if oxygen reduces ischemic pain during PCI for stable angina or NSTEMI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable angina or NST-ACS undergoing PCI
排除标准
- •Blood oxygen <95%
- •Cognitive dysfunction
- •Intubation
研究组 & 干预措施
Nasal oxygen
3 liter per minute
干预措施: Nasal oxygen (Drug)
Nasal Air
3 l regular nasal air
干预措施: Regular nasal air (Drug)
结局指标
主要结局
Chest pain measured with VAS
时间窗: 1 h
After PCI patient is asked in a double blinded about maximum chest during PCI.
次要结局
- Troponin-levels after PCI(2 days)