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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04878887
Other study ID # DRA UTRAC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 26, 2021
Est. completion date December 15, 2022

Study information

Verified date June 2023
Source University Tunis El Manar
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patients were randomly divided into two groups: ultrasound-guided (US-guided) in-plane distal radial access (IP-DRA) and in-plane proximal radial access (IP-PRA) catheterization. For IP-DRA , a linear transducer is placed in the radial fossa, which is known as the snuff-box. After obtaining a long-axis view of the radial artery ,the needle is inserted in the midpoint of the small footprint transducer. Then,the needle is advanced under real-time US guidance until visualizing the tip of the needle inside the artery . For IP-PRA , a linear transducer is placed in the standard conventional forearm radial. After obtaining a long-axis view of the radial artery ,the needle is inserted in the midpoint of the small footprint transducer. Then,the needle is advanced under real-time US guidance until visualizing the tip of the needle inside the artery .


Description:

*Ultrasound-guided catheterization of the radial artery, by proximal approach: - Patient's hand in hyperextension with slight dorsiflexion of the wrist. - The placement of the ultrasound probe initially linear in order to obtain the "short axis" image of the artery; then a quarter turn until obtaining a longitudinal "long axis" view. - The operator must identify the artery using the pulsed wave Doppler; - Insertion of the needle in the middle of the transducer providing an "in plane" orientation. Thus the needle was advanced slowly and its tip was visualized throughout the procedure. *Ultrasound-guided catheterization of the radial artery, by distal approach: - If the right hand is along the body / if the left hand is on the trunk. - The ultrasound probe placed at the level of the anatomical snuffbox by placing the transducer in a linear fashion then rotated coronally until a longitudinal image is obtained *In the 2 groups: - The longitudinal "in plane" approach is used - After visualization of the penetration of the bevel of the needle into the lumen of the artery and the jet of arterial blood into the syringe on aspiration, a flexible metal guide was introduced into the artery through the trocar according to the Seldinger's method. - The correct positioning of the guide in the artery was then confirmed by ultrasound. Any obstacle preventing insertion of the guide system always led to a new puncture.


Recruitment information / eligibility

Status Completed
Enrollment 94
Est. completion date December 15, 2022
Est. primary completion date October 20, 2022
Accepts healthy volunteers No
Gender All
Age group 15 Years to 90 Years
Eligibility Inclusion Criteria: - Patients admitted in intensive care unit requiring a central venous catheter (CVC) Exclusion Criteria: - Patients with radial AV shunt for hemodialysis - Patients with Renaud phenomenon or lymphedema - Congenital or acquired deformity of arms - Cannulation site infection, hematoma and surgery

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
IP-DRA vs IP- PRA
Catetherization approach in plane : distal radial artery VS proximal radial artery

Locations

Country Name City State
Tunisia Mrezga Nabeul Tunisie Nabeul

Sponsors (1)

Lead Sponsor Collaborator
University Tunis El Manar

Country where clinical trial is conducted

Tunisia, 

References & Publications (6)

Deepika K, Palaniappan D, Fuhrman T, Saltzmanm B. Anatomic snuffbox radial artery cannulation. Anesth Analg. 2010 Oct;111(4):1078-9. doi: 10.1213/ANE.0b013e3181ef343a. No abstract available. — View Citation

Hansen MA, Juhl-Olsen P, Thorn S, Frederiksen CA, Sloth E. Ultrasonography-guided radial artery catheterization is superior compared with the traditional palpation technique: a prospective, randomized, blinded, crossover study. Acta Anaesthesiol Scand. 2014 Apr;58(4):446-52. doi: 10.1111/aas.12299. Epub 2014 Mar 3. — View Citation

Kiemeneij F. Left distal transradial access in the anatomical snuffbox for coronary angiography (ldTRA) and interventions (ldTRI). EuroIntervention. 2017 Sep 20;13(7):851-857. doi: 10.4244/EIJ-D-17-00079. — View Citation

Kucuk A, Yuce HH, Yalcin F, Boyaci FN, Yildiz S, Yalcin S. Forty-five degree wrist angulation is optimal for ultrasound guided long axis radial artery cannulation in patients over 60 years old: a randomized study. J Clin Monit Comput. 2014 Dec;28(6):567-72. doi: 10.1007/s10877-014-9552-z. Epub 2014 Jan 11. — View Citation

Pyles ST, Scher KS, Vega ET, Harrah JD, Rubis LJ. Cannulation of the dorsal radial artery: a new technique. Anesth Analg. 1982 Oct;61(10):876-8. No abstract available. — View Citation

Sethi S, Maitra S, Saini V, Samra T, Malhotra SK. Comparison of short-axis out-of-plane versus long-axis in-plane ultrasound-guided radial arterial cannulation in adult patients: a randomized controlled trial. J Anesth. 2017 Feb;31(1):89-94. doi: 10.1007/s00540-016-2270-6. Epub 2016 Oct 19. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The overall access time Time from the ultrasound scanning to the ultrasound confirmation of the correct position of the guidewire . During the cannulation procedure
Secondary 2. Puncture Attempts Which is the number of puncture attempts from first one until the successful one During the procedure
Secondary 3. The guidewire time Time from the first skin puncture to the ultrasound confirmation of the correct placement of the guidewire during the procedure
Secondary 4. The access time time between the first skin puncture and the jet of arterial blood during the procedure
Secondary 5. Rare complications Pseudo-aneurysm, AV fistula formation, radial artery dissection, which are assessed by Doppler US. In addition to radial artery eversion or perforation. After 01 weeks of the procedure.
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