Patient Comfort, Success Rate, Procedure Time and Complications During Sheath Insertion by Nurses and Physicians in Connection With Invasive Examination and Treatment of Cardiac Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- pain level
研究概览
简要总结
The aim of project NUSHI is to elucidate, that radial sheath insertion can be performed by nurses and physicians with the same level of comfort and safety.
详细描述
Background: Insertion of sheath in the radial artery in connection with examination and treatment of patients with coronary artery disease is usually performed by specialized invasive cardiologists or trainees. Whether sheath insertion can be performed by nurses with the same level of comfort and pain is uncertain.
Eligibility: Patients referred for coronary angiography (CAG) and/or percutaneous coronary intervention (PCI) due to suspicion of coronary artery disease are included
Randomization: Patients are randomized 1:1 to sheath insertion by nurse or physician
Methods: Insertion of 5 or 6 radial sheaths is performed in local anesthesia
Outcome measures: Comfort and pain level is registered from immediately after sheath insertion until start of CAG/PCI.
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
- 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 suspected of having coronary artery disease
- •with normal puls oxymetry on the right hand
- •understands patient information and accepts to participate
排除标准
- •under consideration for cardiac valve replacement
- •systolic blood pressure persistently >180 mmHg
结局指标
主要结局
pain level
时间窗: through study completion, an average of 1 year
pain level during sheath insertion is measured using a 1 to 10 point numeric rating scale. For pain registration: 0 is no pain and 10 the worst imaginable pain.
comfort level
时间窗: through study completion, an average of 1 year
comfort level during sheath insertion is measured using a 1 to 10 point numeric rating scale. For comfort: 0 is no comfort at all and 10 is the best imaginable comfort.
次要结局
- convertion(through study completion, an average of 1 year)
- time consumption(through study completion, an average of 1 year)
- complications(through study completion, an average of 1 year)
- success rate(through study completion, an average of 1 year)