Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 5:54 AM
Study NCT ID:
NCT07489859
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-24
First Post:
2026-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nurse vs Physician Artery Cannulation
Sponsor:
Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
Organization:
Study Overview
Official Title:
Nurse-performed Versus Physician-performed Radial Artery Cannulation: a Multicenter Randomized Non-inferiority Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARTEDU
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.
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. 
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: