NCT04878887

Brief 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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 26, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 5, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 10, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed
Last Updated

June 6, 2023

Status Verified

June 1, 2023

Enrollment Period

1.6 years

First QC Date

May 5, 2021

Last Update Submit

June 4, 2023

Conditions

Ultrasonography

Keywords

Catheterradial artery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 2. Puncture Attempts

    During the procedure

  • 3. The guidewire time

    during the procedure

  • 4. The access time

    during the procedure

  • 5. Rare complications

    After 01 weeks of the procedure.

Study Arms (2)

IP-DRA

OTHER

In plane distal radial artery catherterization

Procedure: IP-DRA vs IP- PRA

IP-PRA

OTHER

In plane proximal radial artery catherterization

Procedure: IP-DRA vs IP- PRA

Interventions

IP-DRA vs IP- PRAPROCEDURE

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

IP-DRAIP-PRA

Eligibility Criteria

Age15 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mrezga Nabeul Tunisie

Nabeul, 8000, Tunisia

Location

Related 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.

    PMID: 20870991BACKGROUND

  • 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.

    PMID: 24588456BACKGROUND

  • 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.

    PMID: 24414382BACKGROUND

  • 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.

    PMID: 27761661BACKGROUND

  • 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.

    PMID: 28506941BACKGROUND

  • 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.

    PMID: 7125255RESULT

Study Officials

  • Mechaal Ben Ali, Professor

    University Tunis El Manar

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

May 5, 2021

First Posted

May 10, 2021

Study Start

March 26, 2021

Primary Completion

October 20, 2022

Study Completion

December 15, 2022

Last Updated

June 6, 2023

Record last verified: 2023-06

Locations

TU(1)