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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
94

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Tunis El Manar

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 26, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 20, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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