Nurse vs Physician Artery Cannulation (ARTEDU)

March 25, 2026 updated by: Michal Kalina, Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.

Nurse-performed Versus Physician-performed Radial Artery Cannulation: a Multicenter Randomized Non-inferiority Trial

This prospective controlled clinical trial evaluates the effectiveness and safety of radial artery cannulation using the Seldinger technique under ultrasound guidance when performed by two different operator groups: experienced physicians and trained registered nurses. The study aims to determine whether a structured, competency-based training program enables nurses without prior experience in arterial cannulation to achieve comparable outcomes to physicians in terms of first-attempt success rate, procedural efficiency, and complication rates.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective, controlled clinical trial designed to compare the performance of radial artery cannulation using the Seldinger technique under ultrasound guidance between two predefined operator groups: experienced physicians and trained registered nurses. The trial is conducted in tertiary-care hospital settings in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. 

Radial artery cannulation is a commonly performed invasive procedure used for continuous blood pressure monitoring and arterial blood sampling in perioperative and critical care settings. While traditionally performed by physicians, task-sharing strategies supported by structured training programs may expand procedural capacity while maintaining patient safety. 

In this study, physicians in the control group are board-certified anaesthesiologists or intensivists with established experience in arterial cannulation. The intervention group consists of registered nurses who have no prior experience with arterial cannulation but have successfully completed a structured, competency-based educational program. This program incorporates theoretical instruction, simulation-based training, and supervised clinical practice, based on principles of deliberate practice and mastery learning. 

All procedures are performed using a standardized Seldinger technique with ultrasound guidance and identical equipment, under uniform clinical conditions. Patient preparation, sterile technique, and procedural protocols are standardized across both groups. A supervising physician is immediately available during all procedures to ensure patient safety. 

The primary outcome is first-attempt success rate, defined as successful arterial cannulation following a single skin puncture with confirmation by arterial waveform. Secondary outcomes include total procedure time, overall success rate, number of attempts, and incidence of complications such as hematoma, catheter dysfunction, distal ischemia, and need for rescue intervention. 

The study aims to determine whether nurses trained through a structured educational program can achieve procedural outcomes comparable to experienced physicians. The findings may support the implementation of competency-based training pathways and task-sharing models in vascular access procedures, potentially improving healthcare efficiency while maintaining high standards of patient safety. 

Study Type

Interventional

Enrollment (Estimated)

560

Phase

  • Not Applicable

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Nurse with successful completion of the predefined radial artery catheterization educational module
  • Czech board certified anaesthesiologist with obtained competency for radial artery catheterization.

Exclusion Criteria:

  • Absence of competency for radial artery catheterization.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nurse
Cannulation of a radial artery is done by nurse.
Procedure: Radial artery catheterization done by nurse
Cannulation of a radial artery using Seldinger method by nurse.
Active Comparator: Physician
Cannulation of a radial artery is done by physician.
Procedure: Radial artery catheterization done by physician
Cannulation of a radial artery using Seldinger method by physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First successful attempt
Time Frame: From the first puncture of the patient's skin until the end of catheterization for maximum time of 20 minutes
Number of first successful attempt
From the first puncture of the patient's skin until the end of catheterization for maximum time of 20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to complete catheterization
Time Frame: From the first puncture of the patient's skin until the end of catheterization for maximum time of 20 minutes
Time from firs puncture of a patient's skin to complete successful catheter insertion.
From the first puncture of the patient's skin until the end of catheterization for maximum time of 20 minutes
Complication rate
Time Frame: From the first puncture of the patient's skin until the extraction of the catheter for maximum time of 7 days
Number of complications related to radial artery catheterization.
From the first puncture of the patient's skin until the extraction of the catheter for maximum time of 7 days

Collaborators and Investigators

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

Sponsor

Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.

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 (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

March 18, 2026

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 24, 2026

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ARTEDU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

The data will be available after publishing the study. The data will be available for 10 years.

IPD Sharing Access Criteria

Data will be accessible publicly in university data repository.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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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