Myocardial Ischemia Clinical Trial
— RadialHUSOfficial 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
Verified date | September 2023 |
Source | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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%.
Status | Active, not recruiting |
Enrollment | 368 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 27, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Fundación Jiménez Díaz | Madrid |
Lead Sponsor | Collaborator |
---|---|
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz |
Spain,
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. — View Citation
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. — View Citation
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. — View Citation
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. Erratum In: Lancet. 2011 Apr 23;377(9775):1408. Lancet. 2011 Jul 2;378(9785):30. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Rate of possible complications | 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 | |
Secondary | Perceived pain | 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 |
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