Venipuncture Via Nurse-AI Collaboration

NCT07854626 | Not Yet Recruiting

• 1 other identifier: SYSKY-2025-679-03
• Study Type: interventional
• Target: 3,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peripheral Venous Cannulation for Contrast-enhanced CT/MRI Examination; Peripheral Venous Access Establishment

Keywords

Peripheral venous cannulation; Artificial intelligence; Contrast-enhanced CT; Contrast-enhanced MRI; Venipuncture

Outcome Measures

Primary Outcomes (1)

• 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.

  At the time of venous cannulation (intra-procedure)

Secondary Outcomes (4)

• Time consumed for peripheral venous cannulation

  At the time of venous cannulation (intra-procedure)

• Patient-reported puncture pain score

  Immediately after venous cannulation

• Overall peripheral venous cannulation success rate

  At the time of venous cannulation (intra-procedure)

• Incidence of contrast extravasation and local vascular injury

  From cannulation to 24 hours after contrast injection

Study Arms (2)

AI-assisted Human-machine Coordinated Venipuncture

EXPERIMENTAL

Nurses perform peripheral venous cannulation for contrast-enhanced CT/MRI guided by an AI puncture site recommendation system. Nurses may accept, modify or reject AI suggestions under standardized human-machine coordination rules.

Procedure: AI-assisted human-machine coordinated peripheral venipuncture

Routine Venipuncture

ACTIVE COMPARATOR

Nurses perform peripheral venous cannulation for contrast-enhanced CT/MRI using conventional clinical practice, with puncture site selection based only on clinical experience and visual inspection.

Procedure: Conventional routine peripheral venipuncture

Interventions

AI-assisted human-machine coordinated peripheral venipuncture PROCEDURE

Peripheral 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.

AI-assisted Human-machine Coordinated Venipuncture

Conventional routine peripheral venipuncture PROCEDURE

Standard peripheral venous cannulation for contrast-enhanced CT/MRI without AI assistance. Nurses select puncture sites by visual assessment and clinical experience.

Routine Venipuncture

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Patients planned for Iodine-131 therapy within the next two weeks.
• Extremely poor vascular conditions that make indwelling needle cannulation impossible.
• Patients receiving contrast-enhanced imaging of both upper limbs.
• Known contraindications to contrast media.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead
• Eighth Affiliated Hospital, Sun Yat-sen University: collaborator
• The First People's Hospital of Kashgar Erea: collaborator

Study Sites (1)

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510120, China

Location

Central Study Contacts

Hong Deng, Master of Nursing

CONTACT

+86-13580559211; dengh53@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned at a 1:1 ratio to 2 parallel arms using stratified block randomization, stratified by study center, operator seniority, and venous condition grade.

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: October 2, 2026

Record last verified: 2025-10

Locations

CN (1)