Venipuncture Via Nurse-AI Collaboration

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • AI-assisted human-machine coordinated peripheral venipuncture

    Procedure/Surgery

    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.

  • Conventional routine peripheral venipuncture

    Procedure/Surgery

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

Treatment groups

3,500 Participants
are divided into 2 treatment groups
Group A: AI-assisted Human-machine Coordinated VenipunctureExperimental treatment 1 intervention
Group B: Routine VenipunctureActive comparator 1 intervention

Trial outcomes

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.

Time frame
At the time of venous cannulation (intra-procedure)

Secondary outcomes

1

Time consumed for peripheral venous cannulation

Time duration from touching the skin for puncture preparation to successful venous catheter placement, recorded in seconds.

Time frame
At the time of venous cannulation (intra-procedure)
2

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.

Time frame
Immediately after venous cannulation
3

Overall peripheral venous cannulation success rate

Proportion of participants with successful venous access within maximum allowed puncture attempts.

Time frame
At the time of venous cannulation (intra-procedure)
4

Incidence of contrast extravasation and local vascular injury

Rate of adverse events including contrast medium extravasation, local hematoma and phlebitis related to venous puncture.

Time frame
From cannulation to 24 hours after contrast injection

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

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