About this trial
The goal of this clinical trial is to learn if AI-assisted site selection plus human-machine coordinated puncture improves the quality and safety of peripheral venous access for contrast-enhanced imaging in patients of all ages needing CT/MR contrast scans across three hospitals. The main questions it aims to answer are:
Does the AI-assisted workflow improve the composite success rate of venous cannulation compared with routine nursing? Does this human-machine model raise first-attempt puncture success, shorten procedure time and reduce complications? Researchers will compare the AI-assisted intervention group to the routine nursing control group to see if the AI-assisted human-machine coordinated puncture brings clinical benefits.
Participants will:
* Receive peripheral venous cannulation for contrast-enhanced imaging. * Have arm images and clinical data collected before and after puncture. * Complete standardized venous access assessment and 24-hour post-procedure safety observation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients of all ages scheduled for contrast-enhanced CT/MR examination at three participating centers, who require peripheral venous access.
Recent renal function test showing estimated glomerular filtration rate (eGFR) > 30 ml/min/1.73 m².
Written informed consent obtained from the patient or legal representative, agreeing to radiology specialized nursing service.
Disqualifiers
Patients with irreversible brain injury or brain death.
Contraindications to peripheral venipuncture, including history of bilateral mastectomy, extremity venous thrombosis, etc.
eGFR ≤ 30 ml/min/1.73 m².
Uncontrolled hyperthyroidism.
Trial design
Parallel
Treatments tested in this trial
AI-assisted human-machine coordinated peripheral venipuncture
Procedure/SurgeryPeripheral venous cannulation for contrast-enhanced CT/MRI with AI-guided puncture site recommendation. Nurses operate under standardized human-machine coordination rules and may accept, modify or reject AI site suggestions.
Conventional routine peripheral venipuncture
Procedure/SurgeryStandard peripheral venous cannulation for contrast-enhanced CT/MRI without AI assistance. Nurses select puncture sites by visual assessment and clinical experience.
Treatment groups
Trial outcomes
Primary outcomes
First-attempt success rate of peripheral venous cannulation
The proportion of participants with successful peripheral venous cannulation on the first puncture attempt for contrast-enhanced CT/MRI. Success is defined as blood return in the catheter and unobstructed contrast medium injection.
Secondary outcomes
Time consumed for peripheral venous cannulation
Time duration from touching the skin for puncture preparation to successful venous catheter placement, recorded in seconds.
Patient-reported puncture pain score
Pain intensity assessed by 10-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain) immediately after cannulation.
Overall peripheral venous cannulation success rate
Proportion of participants with successful venous access within maximum allowed puncture attempts.
Incidence of contrast extravasation and local vascular injury
Rate of adverse events including contrast medium extravasation, local hematoma and phlebitis related to venous puncture.
Sponsors and contacts
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead sponsor
Eighth Affiliated Hospital, Sun Yat-sen University
Collaborator
The First People's Hospital of Kashgar Erea
Collaborator
This trial is not recruiting at the moment. You can still explore other options: