NCT07489859

Brief Summary

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
560

participants targeted

Target at P75+ for not_applicable

Timeline
24mo left

Started May 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
May 2026Aug 2028

First Submitted

Initial submission to the registry

March 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

March 18, 2026

Last Update Submit

March 25, 2026

Conditions

Keywords

educationnurse competencyarterial catheterizationseldinger methodcompetency based educationsimulation based medical education

Outcome Measures

Primary Outcomes (1)

  • First successful attempt

    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 Outcomes (2)

  • Time to complete catheterization

    From the first puncture of the patient's skin until the end of catheterization for maximum time of 20 minutes

  • Complication rate

    From the first puncture of the patient's skin until the extraction of the catheter for maximum time of 7 days

Study Arms (2)

Nurse

EXPERIMENTAL

Cannulation of a radial artery is done by nurse.

Procedure: Radial artery catheterization done by nurse

Physician

ACTIVE COMPARATOR

Cannulation of a radial artery is done by physician.

Procedure: Radial artery catheterization done by physician

Interventions

Cannulation of a radial artery using Seldinger method by nurse.

Nurse

Cannulation of a radial artery using Seldinger method by physician.

Physician

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Absence of competency for radial artery catheterization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
deputy for science and research

Study Record Dates

First Submitted

March 18, 2026

First Posted

March 24, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

August 1, 2028

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP
Time Frame
The data will be available after publishing the study. The data will be available for 10 years.
Access Criteria
Data will be accessible publicly in university data repository.