CClinicalTrials.gg
CompletedNCT04878887Updated Jun 6, 2023

DRA vs PRA for US-guided Radial Artery Catheterization in ICU

An interventional study of IP-DRA vs IP- PRA in Ultrasonography, sponsored by University Tunis El Manar. Completed at 1 site in Tunisia. Open to participants aged 15 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-06-06.

Sponsored by University Tunis El Manar · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
94
Allocation
Randomized
Ages
15 Years to 90 Years
Sex
All
01

Study 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 .

Read the detailed 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.
02

Conditions studied

  • Ultrasonography

Keywords

  • Catheter
  • radial artery
03

In context

Lead sponsor

University Tunis El Manar is the lead sponsor of 73 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients admitted in intensive care unit requiring a central venous catheter (CVC)

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
94 participants (actual)

Study arms

  • Other
    IP-DRA

    In plane distal radial artery catherterization

    Procedure: IP-DRA vs IP- PRA

  • Other
    IP-PRA

    In plane proximal radial artery catherterization

    Procedure: IP-DRA vs IP- PRA

Interventions

  • ProcedureIP-DRA vs IP- PRA

    Catetherization approach in plane : distal radial artery VS proximal radial artery

06

What researchers measure

Primary outcomes

  1. The overall access time

    Time from the ultrasound scanning to the ultrasound confirmation of the correct position of the guidewire .

    Time frame: During the cannulation procedure

Secondary outcomes

  1. 2. Puncture Attempts

    Which is the number of puncture attempts from first one until the successful one

    Time frame: During the procedure

  2. 3. The guidewire time

    Time from the first skin puncture to the ultrasound confirmation of the correct placement of the guidewire

    Time frame: during the procedure

  3. 4. The access time

    time between the first skin puncture and the jet of arterial blood

    Time frame: during the procedure

  4. 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.

    Time frame: After 01 weeks of the procedure.

07

Study locations

1 site
  • Mrezga Nabeul Tunisie
    Nabeul, 8000, Tunisia
08

References and documents

Publications

  • 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. PubMed 20870991 ↗
  • 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. PubMed 24588456 ↗
  • 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. PubMed 24414382 ↗
  • 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. PubMed 27761661 ↗
  • 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. PubMed 28506941 ↗
  • 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. PubMed 7125255 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04878887
Lead sponsor
University Tunis El Manar
Responsible party
Trabelsi Becem (associate professor, University Tunis El Manar) — Principal investigator
First posted
May 10, 2021
Start date
Mar 26, 2021
Primary completion
Oct 20, 2022
Completion
Dec 15, 2022
Last update
Jun 6, 2023

Study contacts

Mechaal Ben Ali, Professor
study chair · University Tunis El Manar

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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