Randomized Clinical Trial on the Effect of Reactive Hyperemia and Ultrasound-guided Puncture on the Success Rate of Radial Artery Cannulation in Patients Undergoing Cardiac Catheterization
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 368
- 试验地点
- 1
- 主要终点
- Time to cannulate
研究概览
简要总结
Aims: to evaluate the success rate of radial artery cannulation in patients undergoing cardiac catheterization, using different methods such as palpation, hyperemia or ultrasound-guided puncture, together or each method separately. Specifically, the success rate at the first attempt, the number of attempts with each technique and the time spent will be assessed.
The hypothesis is that there are different success rates for each puncture technique when cannulating radial artery for cardiac catheterization.
Methods: randomized clinical trial with four parallel groups, with operator blinding. Those patients who will have the radial artery cannulated for an interventional cardiology procedure will be selected.
Once the participant agrees to be included in the study and signs the informed consent, they are randomized to one of four groups: ultrasound and hyperemia puncture, only ultrasound puncture, only hyperemia puncture, palpation puncture (control group). Subsequently, an ultrasound assessment of the participant's radial artery (diameter, depth and systolic peak velocity) will be performed. Once in the intervention room, the puncture will be performed according to the corresponding method. The puncturing operator in charge will not perform the randomization or the ultrasound assessment to avoid bias.
Variables will be collected in an ad hoc questionnaire designed to respond all study aims. Regarding the sample size, accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast, 92 subjects per group are required to detect significant differences. Therefore, the total sample size would be made up of 368 participants, estimating losses of 5%.
For variables description and hypotheses contrast, the statistical program SPSS version 22.0 for Windows will be used, working with a significance level of 5%.
详细描述
Background: ultrasound-guided puncture seems to facilitate cannulation of the radial artery in patients who undergoing cardiac catheterization. The efficacy of reactive hyperemia has also been seen, however, the combination of different methods in radial artery puncture has not been evaluated.
Aims: to evaluate the success rate of radial artery cannulation in patients undergoing cardiac catheterization, using different methods such as palpation, hyperemia or ultrasound-guided puncture, together or each method separately. Specifically, success rate at the first attempt, attempts numbers with each technique and time spent will be assessed. Possible complications and perceived pain by the participant in each technique will be evaluated.
The hypothesis is that there are different success rates for each puncture technique when cannulating radial artery for cardiac catheterization.
Methods: randomized clinical trial with four parallel groups, with operator blinding.
Participation in the clinical trial does not imply an increased risk for the patient since both ultrasound and hyperemia are harmless and non-invasive methods.
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
- 是
入选标准
- •over 18 years of age
- •understand, accept and sign the informed consent
- •participants undergoing radial artery cannulation for a diagnostic, therapeutic, or structural interventional cardiology procedure
- •patent radial artery in the previous ultrasound evaluation
排除标准
- •systolic blood pressure greater than 150mmHg
- •diagnosis of acute myocardial infarction (with or without ST-segment elevation)
- •previous surgeries that have affected the arterial system of the upper limbs (arteriovenous fistula, radial artery for bypass surgery, etc.)
- •language barrier that hinders a clear study understanding for potential participant
研究组 & 干预措施
Ultrasound and hyperemia
Use of ultrasound and hyperemia to puncture radial artery.
干预措施: Methods for cannulating the radial artery in a cardiac catheterization (Procedure)
Ultrasound only
Use of ultrasound only to puncture radial artery.
干预措施: Methods for cannulating the radial artery in a cardiac catheterization (Procedure)
Hyperemia only
Use of hyperemia and palpation to puncture radial artery.
干预措施: Methods for cannulating the radial artery in a cardiac catheterization (Procedure)
Palpation
Use of palpation to puncture radial artery (control group).
结局指标
主要结局
Time to cannulate
时间窗: During radial artery cannulation, the time will be measured from the needle is inserted into the skin for the first time until the guidewire enters the arterial lumen, stopping time when the needle is out of the skin (if more than one puncture)
The time in minutes and seconds has been necessary to cannulate radial artery will be measured
Rate of success at first puncture attempt
时间窗: During radial artery puncture, it will be assessed whether cannulation can be achieved at the first attempt
It is assessed whether the radial artery is cannulated in the first puncture without removing the needle from the skin
Number of punctures
时间窗: During radial artery cannulation, punctures number have been necessary will be measured
The punctures number have been necessary to achieve radial artery cannulation will be measured
次要结局
- Rate of possible complications(During or just after the cardiac catheterization, the possible complications related to the arterial puncture will be assessed)
- Perceived pain(The perceived pain will be recorded at the end of the radial artery cannulation)