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

NCT05364463 | Unknown

• 1 other identifier: EC093-21_FJD
• Study Type: interventional
• Target: 368
• Locations: 1 country
• Sites: 1

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%.

Conditions

Myocardial Ischemia; Cardiac Catheterization

Keywords

Radial Artery; Hyperemia; Ultrasonography

Outcome Measures

Primary Outcomes (3)

• Rate of success at first puncture 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

• Number of punctures

  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

  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)

Secondary Outcomes (2)

• Rate of possible complications

  During or just after the cardiac catheterization, the possible complications related to the arterial puncture will be assessed

• Perceived pain

  The perceived pain will be recorded at the end of the radial artery cannulation

Study Arms (4)

Ultrasound and hyperemia

EXPERIMENTAL

Use of ultrasound and hyperemia to puncture radial artery.

Procedure: Methods for cannulating the radial artery in a cardiac catheterization

Ultrasound only

EXPERIMENTAL

Use of ultrasound only to puncture radial artery.

Procedure: Methods for cannulating the radial artery in a cardiac catheterization

Hyperemia only

EXPERIMENTAL

Use of hyperemia and palpation to puncture radial artery.

Procedure: Methods for cannulating the radial artery in a cardiac catheterization

Palpation

NO INTERVENTION

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

Interventions

Methods for cannulating the radial artery in a cardiac catheterization 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; Ultrasound and hyperemia; Ultrasound only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: lead

Study Sites (1)

Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Related Publications (7)

• Deftereos S, Giannopoulos G, Kossyvakis C, Driva M, Kaoukis A, Raisakis K, Theodorakis A, Panagopoulou V, Lappos S, Tampaki E, Pyrgakis V, Stefanadis C. Radial artery flow-mediated dilation predicts arterial spasm during transradial coronary interventions. Catheter Cardiovasc Interv. 2011 Apr 1;77(5):649-54. doi: 10.1002/ccd.22688.

  PMID: 20549693 BACKGROUND

• Jolly SS, Yusuf S, Cairns J, Niemela K, Xavier D, Widimsky P, Budaj A, Niemela M, Valentin V, Lewis BS, Avezum A, Steg PG, Rao SV, Gao P, Afzal R, Joyner CD, Chrolavicius S, Mehta SR; RIVAL trial group. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet. 2011 Apr 23;377(9775):1409-20. doi: 10.1016/S0140-6736(11)60404-2. Epub 2011 Apr 4.

  PMID: 21470671 BACKGROUND

• Doubell J, Kyriakakis C, Weich H, Herbst P, Pecoraro A, Moses J, Griffiths B, Snyman HW, Kabwe L, Du Toit R, Joubert L, Hassan K, Doubell A. Radial artery dilatation to improve access and lower complications during coronary angiography: the RADIAL trial. EuroIntervention. 2021 Mar 19;16(16):1349-1355. doi: 10.4244/EIJ-D-19-00207.

  PMID: 31746742 BACKGROUND

• Thijssen DHJ, Bruno RM, van Mil ACCM, Holder SM, Faita F, Greyling A, Zock PL, Taddei S, Deanfield JE, Luscher T, Green DJ, Ghiadoni L. Expert consensus and evidence-based recommendations for the assessment of flow-mediated dilation in humans. Eur Heart J. 2019 Aug 7;40(30):2534-2547. doi: 10.1093/eurheartj/ehz350.

  PMID: 31211361 BACKGROUND

• Lanza GA, Cesarano M, De Vita A, Villano A, Milo M, Russo G, Crea F. Effect of Remote Ischemic Preconditioning on Coronary Procedure-Related Impairment of Vascular Dilator Function. J Am Coll Cardiol. 2016 Dec 6;68(22):2490-2492. doi: 10.1016/j.jacc.2016.08.071. No abstract available.

  PMID: 27908357 BACKGROUND

• Seto AH, Roberts JS, Abu-Fadel MS, Czak SJ, Latif F, Jain SP, Raza JA, Mangla A, Panagopoulos G, Patel PM, Kern MJ, Lasic Z. Real-time ultrasound guidance facilitates transradial access: RAUST (Radial Artery access with Ultrasound Trial). JACC Cardiovasc Interv. 2015 Feb;8(2):283-291. doi: 10.1016/j.jcin.2014.05.036. Epub 2015 Jan 14.

  PMID: 25596790 BACKGROUND

• Jayanti S, Juergens C, Makris A, Hennessy A, Nguyen P. The Learning Curves for Transradial and Ultrasound-Guided Arterial Access: An Analysis of the SURF Trial. Heart Lung Circ. 2021 Sep;30(9):1329-1336. doi: 10.1016/j.hlc.2021.02.006. Epub 2021 Mar 12.

  PMID: 33722490 BACKGROUND

Related Links

• ESC Guidelines

MeSH Terms

Conditions

Myocardial Ischemia; Hyperemia

Interventions

Methods

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Juan C Sánchez, RN, BsC, MSc

  Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 6, 2022
• Study Start: February 17, 2022
• Primary Completion: December 27, 2022
• Study Completion: December 31, 2023
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)