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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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

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

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 (Estimated)

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.
560

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

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

  • 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

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.
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

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
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

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
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

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.
May 1, 2026

Primary Completion (Estimated)

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.
May 1, 2027

Study Completion (Estimated)

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.
August 1, 2028

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).
March 18, 2026

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.
March 18, 2026

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.
March 24, 2026

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.
March 31, 2026

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.
March 25, 2026

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.
March 1, 2026

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.
  • 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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