- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07248683
Application of Intermittent Training in Radial Artery Puncture and Catheterization Skills Under Ultrasound-Guided Line Guidance
Application of Ultrasound-Guided Midline Combined With Spaced Retrieval Training in Radial Artery Puncture and Catheterization for Standardized-Trained Residents:A Randomized Sequential Allocation Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Zhihua Wang, PhD
- Phone Number: 86-0951-18295111380
- Email: 846522050@qq.com
Study Contact Backup
- Name: Haoyao Ren, MS
- Phone Number: 86-0951-18509342993
- Email: 736695348@qq.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion and Exclusion Criteria for Study Participants (Resident Trainees) I. Inclusion Criteria Identity and Qualifications: Resident physicians undergoing standardized training in this department.
Training Stage: Resident physicians who have not yet independently performed ultrasound-guided radial artery puncture and catheterization procedures.
Willingness to Learn: Voluntary participation in this "Ultrasound-Guided Radial Artery Catheterization" training program with full understanding of the research content.
Informed Consent: Have signed a written informed consent form agreeing to participate in this study and comply with protocol requirements.
Basic Requirements: Possess good hand-eye coordination and learning ability, capable of cooperating to complete the entire training course and data collection.
II. Exclusion Criteria Prior Experience: Residents who have previously independently completed more than 5 cases or have systematically studied ultrasound-guided radial artery puncture and catheterization techniques.
Skill Level: Residents who achieved a high pre-test performance score or demonstrated consistent success in performing ultrasound-guided radial artery catheterization prior to the study.
Cognitive or Motor Impairment: Residents with severe cognitive dysfunction, motor impairment, or a history of psychiatric disorders that may compromise training efficacy assessment.
Time Commitment and Compliance: Individuals unable to guarantee completion of the prescribed training program, practical exercises, and follow-up evaluations.
Other Conditions: Participants deemed unsuitable for this study by the investigator due to other reasons (e.g., rotation schedule conflicts, inability to coordinate personal time, etc.).
Inclusion and Exclusion Criteria for Study Subjects (Patients Undergoing Radial Artery Catheterization)
I. Inclusion Criteria
Age: Generally ≥18 years old. Clinical Indications: Patients requiring invasive arterial pressure monitoring via radial artery puncture and catheterization due to surgical procedures, critical condition monitoring, or blood gas analysis.
Vascular Criteria: Palpable radial artery pulse on the puncture side, negative modified Allen test (or adequate ulnar artery compensation as determined by current guidelines).
Informed Consent: Patient or authorized family member fully understands the study purpose and procedures, and has signed a written informed consent form.
Cooperation Capacity: Able to cooperate throughout the radial artery puncture and catheterization procedure.
II. Exclusion Criteria Contraindications for Puncture: History of thrombosis, aneurysm, or arteriovenous fistula at the puncture site; skin infection, laceration, burn, or severe scar tissue at the puncture site.
Circulatory Impairment: Severe shock, hypovolemic state, or anticipated difficulty with radial artery puncture.
Coagulation Abnormalities: Significant bleeding tendency, marked thrombocytopenia, or ongoing anticoagulant/antiplatelet therapy without discontinuation.
Abnormal vascular anatomy: Preliminary ultrasound assessment indicates severe tortuosity, malformation, excessively narrow diameter, or other significant anatomical variations in the radial artery that may compromise puncture success or safety.
Special circumstances: Requirement for simultaneous bilateral radial artery catheterization; or other situations deemed unsuitable for this teaching procedure by the investigator.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Interval Training Group
All participants underwent centralized training.
The intermittent retraining group performed fixed-interval repeated training, executing the same tasks daily on days 3, 7, and 14.
|
Through basic skills training and testing, it was confirmed that all trainees had mastered the procedural steps for radial artery puncture and catheterization guided by ultrasound midline imaging.
Testing also validated the students' proficiency in performing this procedure.
The intermittent retraining group underwent repeated training at fixed intervals, performing the same tasks daily on days 3, 7, and 14.
|
|
Experimental: Non-interval retraining
Through centralized training, it was confirmed that all trainees had mastered the steps of radial artery puncture and catheterization guided by the midline ultrasound.
A test validated the students' proficiency in this procedure.
The non-intermittent retraining group will not undergo intermittent training during the following week.
|
Through basic skills training and testing, it was confirmed that all trainees had mastered the procedural steps for radial artery puncture and catheterization guided by ultrasound midline imaging.
Testing also validated the students' proficiency in performing this procedure.
The non-intermittent retraining group did not repeat the same tasks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
First Attempt Catheterization Success Rate
Time Frame: The fourteenth day after the unified training
|
The percentage of cases where the operator successfully punctures the target vessel (specifically the radial artery in my study) on the first attempt and advances the catheter to the desired position.
This process requires no additional puncture attempts, catheter adjustments, or encounters procedural failure (such as unsuccessful vessel entry, guidewire/catheter entanglement, abnormal positioning, or immediate complications like hematoma formation).
|
The fourteenth day after the unified training
|
|
First-Attempt Radial Artery Catheterization Success Rate
Time Frame: The 14th day after training
|
First-Attempt Success Rate of Radial Artery Catheterization Guided by Ultrasound Median Line
|
The 14th day after training
|
|
Incidence of complications
Time Frame: The 14th day after training
|
Incidence of Complications in Radial Artery Puncture and Catheterization Guided by Ultrasound Midline
|
The 14th day after training
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Haoyao Ren--2025-11
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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