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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

368 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-17

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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%.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Subcutaneous NTG for US Radial Artery Cannulation

NCT03006640

Morbid Obesity

COMPLETED NA

Better Arterial Cannulation Technique With Different Hemodynamics

NCT02825615

Acute Respiratory Failure Shock

COMPLETED NA

Comparison of the Modified and Conventional Approach of Radial Artery Cannulation Under Short-axis Ultrasound Guidance in ICU Hypotensive Patients.

NCT04806932

Radial Artery Catheterization

UNKNOWN NA

Ultrasound-guided Versus Direct Palpation Radial Artery Catheter Insertion Among Cardiac Anesthesiologists

NCT02118441

Time to Insertion of Radial Artery Cannulation

COMPLETED NA

Ultrasound-guided In-plane Puncture of the Femoral Artery

NCT06065943

Vessel Puncture Site Bleeding

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

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 (for hyperemia, a blood pressure cuff is inflated 50mmHg above systolic until a maximum of 200mmHg for 5 minutes before puncture, it is known that maximum hyperemia is achieved 60 to 180 seconds after deflation), ultrasound puncture only, hyperemia puncture only, palpation puncture (control group).

Similarly, before the puncture, 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 will not perform the randomization or the ultrasound assessment to avoid bias.

Participation in the study ends once the radial artery has been cannulated with the guide according to the Seldinger technique.

The randomization sequence was generated by the center's Biostatistics and Epidemiology Unit. The four possible puncture methods were stratified by operator.

All operators have performed hundreds of radial punctures by palpation and more than 20 ultrasound-guided punctures, as established by the study of the learning curve carried out by Jayanti S et al, before starting participants recruitment.

All the variables will be collected in an ad hoc questionnaire designed to respond all study objectives.

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 a statistically significant difference, which for the control group (traditional puncture) is expected to be 0.44 the percentage of success at the first puncture attempt, and for the rest is at least 0.65. Therefore, the total sample size would be made up of 368 participants, estimating a follow-up loss of 5%.

Regarding the statistical analysis, the quantitative variables will be described with the mean and the standard deviation if they follow a normal distribution, or with the median and the interquartile range if they do not follow a normal distribution. The normality will be contrasted using the Kolmogorov-Smirnov test. The qualitative variables will be described through the distribution of frequencies and percentages.

For the comparisons of the quantitative variables following a normal distribution, the one factor analysis of variance (ANOVA) will be used for the global comparison, and the Student's t-test in the comparisons by pairs. For variables do not following a normal distribution, the Kruskal Wallis test will be used in the global comparison, and Dunn's test in pairwise comparisons. For comparisons of qualitative variables, the Chi-square test will be used, or Fisher's exact test in those situations in which the criteria for using the Chi-square are not met. In pairwise comparisons, the Bonferroni correction will be applied for multiple comparisons.

In all hypothesis contrasts, a significance level of 5% will be used. The statistical program SPSS version 22.0 for Windows will be used.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myocardial Ischemia Cardiac Catheterization

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ultrasound and hyperemia

Use of ultrasound and hyperemia to puncture radial artery.

Group Type EXPERIMENTAL

Methods for cannulating the radial artery in a cardiac catheterization

Intervention Type PROCEDURE

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

Ultrasound only

Use of ultrasound only to puncture radial artery.

Group Type EXPERIMENTAL

Methods for cannulating the radial artery in a cardiac catheterization

Intervention Type PROCEDURE

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

Hyperemia only

Use of hyperemia and palpation to puncture radial artery.

Group Type EXPERIMENTAL

Methods for cannulating the radial artery in a cardiac catheterization

Intervention Type PROCEDURE

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

Palpation

Use of palpation to puncture radial artery (control group).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes