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

June 4, 2023 updated by: Trabelsi Becem, University Tunis El Manar

Comparaison Between Ultrasound-guided Distal and Proximal Approaches for Radial Artery Catheterization in Intensive Care Unit

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Nabeul, Tunisia, 8000
        • Mrezga Nabeul Tunisie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: IP-DRA
In plane distal radial artery catherterization
Procedure: IP-DRA vs IP- PRA
Catetherization approach in plane : distal radial artery VS proximal radial artery
Other: IP-PRA
In plane proximal radial artery catherterization
Procedure: IP-DRA vs IP- PRA
Catetherization approach in plane : distal radial artery VS proximal radial artery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The overall access time
Time Frame: During the cannulation procedure
Time from the ultrasound scanning to the ultrasound confirmation of the correct position of the guidewire .
During the cannulation procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2. Puncture Attempts
Time Frame: During the procedure
Which is the number of puncture attempts from first one until the successful one
During the procedure
3. The guidewire time
Time Frame: during the procedure
Time from the first skin puncture to the ultrasound confirmation of the correct placement of the guidewire
during the procedure
4. The access time
Time Frame: during the procedure
time between the first skin puncture and the jet of arterial blood
during the procedure
5. Rare complications
Time Frame: After 01 weeks of the procedure.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Tunis El Manar

Investigators

  • Study Chair: Mechaal Ben Ali, Professor, University Tunis El Manar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2021

Primary Completion (Actual)

October 20, 2022

Study Completion (Actual)

December 15, 2022

Study Registration Dates

First Submitted

May 5, 2021

First Submitted That Met QC Criteria

May 6, 2021

First Posted (Actual)

May 10, 2021

Study Record Updates

Last Update Posted (Actual)

June 6, 2023

Last Update Submitted That Met QC Criteria

June 4, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DRA UTRAC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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