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

September 27, 2023 updated by: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

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

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%.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

368

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Fundacion Jimenez Diaz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of punctures
Time Frame: 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
During radial artery cannulation, punctures number have been necessary will be measured
Time to cannulate
Time Frame: 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
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)
Rate of success at first puncture attempt
Time Frame: 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
During radial artery puncture, it will be assessed whether cannulation can be achieved at the first attempt

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived pain
Time Frame: 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
The perceived pain will be recorded at the end of the radial artery cannulation
Rate of possible complications
Time Frame: 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.
During or just after the cardiac catheterization, the possible complications related to the arterial puncture will be assessed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2022

Primary Completion (Actual)

December 27, 2022

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

May 3, 2022

First Submitted That Met QC Criteria

May 3, 2022

First Posted (Actual)

May 6, 2022

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC093-21_FJD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

After completing the recruitment, the data collected will be analyzed for publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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