Cardiac Catheterization clinical trials

Effect of Reactive Hyperemia and Ultrasound-guided Puncture on the Success Rate of Radial Artery Cannulation (RadialHUS)

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%.