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

NCT05364463 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 368

Last updated 2023-09-29

No results posted yet for this study

Summary

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%.

Conditions

  • Myocardial Ischemia
  • Cardiac Catheterization

Interventions

PROCEDURE

Methods for cannulating the radial artery in a cardiac catheterization

The puncture will be performed in each participant according to the method has been assigned randomly: ultrasound and hyperemia, ultrasound only, hyperemia only, palpation.

Sponsors & Collaborators

  • Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

    lead OTHER

Principal Investigators

  • Juan C Sánchez, RN, BsC, MSc · Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-17
Primary Completion
2022-12-27
Completion
2023-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05364463 on ClinicalTrials.gov