Nurse-performed Versus Physician-performed Radial Artery Cannulation: a Multicenter Randomized Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 560
- 主要终点
- First successful attempt
研究概览
简要总结
This prospective controlled clinical trial evaluates the effectiveness and safety of radial artery cannulation using the Seldinger technique under ultrasound guidance when performed by two different operator groups: experienced physicians and trained registered nurses. The study aims to determine whether a structured, competency-based training program enables nurses without prior experience in arterial cannulation to achieve comparable outcomes to physicians in terms of first-attempt success rate, procedural efficiency, and complication rates.
详细描述
This study is a prospective, controlled clinical trial designed to compare the performance of radial artery cannulation using the Seldinger technique under ultrasound guidance between two predefined operator groups: experienced physicians and trained registered nurses. The trial is conducted in tertiary-care hospital settings in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. 
Radial artery cannulation is a commonly performed invasive procedure used for continuous blood pressure monitoring and arterial blood sampling in perioperative and critical care settings. While traditionally performed by physicians, task-sharing strategies supported by structured training programs may expand procedural capacity while maintaining patient safety. 
In this study, physicians in the control group are board-certified anaesthesiologists or intensivists with established experience in arterial cannulation. The intervention group consists of registered nurses who have no prior experience with arterial cannulation but have successfully completed a structured, competency-based educational program. This program incorporates theoretical instruction, simulation-based training, and supervised clinical practice, based on principles of deliberate practice and mastery learning. 
All procedures are performed using a standardized Seldinger technique with ultrasound guidance and identical equipment, under uniform clinical conditions. Patient preparation, sterile technique, and procedural protocols are standardized across both groups. A supervising physician is immediately available during all procedures to ensure patient safety. 
The primary outcome is first-attempt success rate, defined as successful arterial cannulation following a single skin puncture with confirmation by arterial waveform. Secondary outcomes include total procedure time, overall success rate, number of attempts, and incidence of complications such as hematoma, catheter dysfunction, distal ischemia, and need for rescue intervention. 
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Nurse with successful completion of the predefined radial artery catheterization educational module
- •Czech board certified anaesthesiologist with obtained competency for radial artery catheterization.
排除标准
- •Absence of competency for radial artery catheterization.
结局指标
主要结局
First successful attempt
时间窗: From the first puncture of the patient's skin until the end of catheterization for maximum time of 20 minutes
Number of first successful attempt
次要结局
- Time to complete catheterization(From the first puncture of the patient's skin until the end of catheterization for maximum time of 20 minutes)
- Complication rate(From the first puncture of the patient's skin until the extraction of the catheter for maximum time of 7 days)
研究者
Michal Kalina
deputy for science and research
Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
