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

Sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz (Other)

Overall Status

Recruiting

CT.gov ID

NCT05364463

Collaborator

(none)

368

Enrollment

Location

Arms

15.4

Anticipated Duration (Months)

23.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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%.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Ischemia Cardiac Catheterization	Procedure: Methods for cannulating the radial artery in a cardiac catheterization	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

368 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Feb 17, 2022

Anticipated Primary Completion Date :

Jan 31, 2023

Anticipated Study Completion Date :

May 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ultrasound and hyperemia Use of ultrasound and hyperemia to puncture radial artery.	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.
Experimental: Ultrasound only Use of ultrasound only to puncture radial artery.	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.
Experimental: Hyperemia only Use of hyperemia and palpation to puncture radial artery.	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.
No Intervention: Palpation Use of palpation to puncture radial artery (control group).

Outcome Measures

Primary Outcome Measures

Success at first puncture attempt [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 [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
Time to cannulate [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

Secondary Outcome Measures

Possible complications [During or just after the cardiac catheterization, the possible complications related to the arterial puncture will be assessed]
Complications that may arise after arterial puncture such as spasm, hematoma, cyanosis, coldness, paresthesia, etc.
Perceived pain [The perceived pain will be recorded at the end of the radial artery cannulation]
The perceived pain by the patient will be recorded on a 0 to 10 scale, with 0 being no pain and 10 being the maximum possible imagined pain

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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