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

Sponsor
University Tunis El Manar (Other)
Overall Status
Recruiting
CT.gov ID
NCT04878887
Collaborator
(none)
60
1
2
8.2
7.3

Study Details

Study Description

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 .

Condition or Disease Intervention/Treatment Phase
  • Procedure: IP-DRA vs IP- PRA
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
Comparaison Between Ultrasound-guided Distal and Proximal Approaches for Radial Artery Catheterization in Intensive Care Unit
Actual Study Start Date :
Mar 26, 2021
Anticipated Primary Completion Date :
Oct 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. The overall access time [During the cannulation procedure]

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

Secondary Outcome Measures

  1. 2. Puncture Attempts [During the procedure]

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

  2. 3. The guidewire time [during the procedure]

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

  3. 4. The access time [during the procedure]

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

  4. 5. Rare complications [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mrezga Nabeul Tunisie Nabeul Tunisia 8000

Sponsors and Collaborators

  • University Tunis El Manar

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Trabelsi Becem, associate professor, University Tunis El Manar
ClinicalTrials.gov Identifier:
NCT04878887
Other Study ID Numbers:
  • DRA UTRAC
First Posted:
May 10, 2021
Last Update Posted:
May 10, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Trabelsi Becem, associate professor, University Tunis El Manar

Study Results

No Results Posted as of May 10, 2021