Peripheral Venous Cannulation for Contrast-enhanced CT/MRI ExaminationNCT07854626
Venipuncture Via Nurse-AI Collaboration
A study testing AI-assisted human-machine coordinated peripheral venipuncture and Conventional routine peripheral venipuncture in people with Peripheral Venous Cannulation for Contrast-enhanced CT/MRI Examination and Peripheral Venous Access Establishment, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Venous Cannulation for Contrast-enhanced CT/MRI Examination, Peripheral Venous Access Establishment
- What is being tested?
- AI-assisted human-machine coordinated peripheral venipuncture and Conventional routine peripheral venipuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,500 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2026to 15 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510120
Hong Deng, Master of Nursing, +86-13580559211, dengh53@mail.sysu.edu.cn
About this study
Official title: Venipuncture Via Nurse-AI Collaboration: A Multi-Center Randomized Controlled 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.
Read more
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.
Read the detailed description
This multicenter prospective randomized controlled trial aims to address the clinical gap of accurate, easy-to-use tools to guide peripheral venous access placement for contrast-enhanced CT and MR imaging. At present, venous puncture site selection mainly relies on nurses' personal experience, which may lead to variable cannulation success rates, prolonged operation time and avoidable procedure-related complications.
The study team will build a multi-modal database integrating patients' BMI, physiological parameters, multi-view visible light and near-infrared arm images. Leveraging deep learning techniques including Neural Radiance Field and Swin-Transformer, an AI model will be developed to reconstruct 3D vascular anatomy and recommend optimal puncture sites. The AI tool serves only as a decision-support aid; final puncture decisions remain with nurses under a standardized human-machine coordination framework, where clinicians may accept, modify or reject AI recommendations.
Three participating hospitals will recruit eligible patients and randomly assign them to either the AI-assisted intervention group or routine nursing control group. Standardized image acquisition, venous assessment checklist documentation and post-procedure safety monitoring will be performed uniformly across both groups to ensure data consistency. The trial will also collect process metrics to characterize real-world human-machine interaction, including AI recommendation acceptance rates and handling strategies when AI suggestions conflict with clinical judgment.
Findings from this trial will validate the clinical value and generalizability of the human-machine coordinated puncture workflow, support future clinical translation of the AI venous localization system, and provide evidence to improve the quality and safety of peripheral venous access for contrast-enhanced imaging examinations.
- Conditions
- Peripheral Venous Cannulation for Contrast-enhanced CT/MRI Examination, Peripheral Venous Access Establishment
- Being tested
- AI-assisted human-machine coordinated peripheral venipuncture, Conventional routine peripheral venipuncture
- Keywords
- Peripheral venous cannulation, Artificial intelligence, Contrast-enhanced CT, Contrast-enhanced MRI, Venipuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-assisted human-machine coordinated peripheral venipunctureProcedure or 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 venipunctureProcedure or surgery
Standard peripheral venous cannulation for contrast-enhanced CT/MRI without AI assistance. Nurses select puncture sites by visual assessment and clinical experience.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Conventional routine peripheral venipuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of venous cannulation (intra-procedure)
Secondary outcomes (4)
Time consumed for peripheral venous cannulation
Time duration from touching the skin for puncture preparation to successful venous catheter placement, recorded in seconds.
Measured: At the time of venous cannulation (intra-procedure)
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.
Measured: Immediately after venous cannulation
Overall peripheral venous cannulation success rate
Proportion of participants with successful venous access within maximum allowed puncture attempts.
Measured: At the time of venous cannulation (intra-procedure)
Incidence of contrast extravasation and local vascular injury
Rate of adverse events including contrast medium extravasation, local hematoma and phlebitis related to venous puncture.
Measured: From cannulation to 24 hours after contrast injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Venous Cannulation for Contrast-enhanced CT/MRI ExaminationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Eighth Affiliated Hospital, Sun Yat-sen University, The First People's Hospital of Kashgar Erea
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854626
- Sponsor's protocol ID
- SYSKY-2025-679-03
- Status last verified
- Oct 2025
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venipuncture Via Nurse-AI Collaboration: A Multi-Center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07854626
- Acronym / sponsor ID
- SYSKY-2025-679-03
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Eighth Affiliated Hospital, Sun Yat-sen University, The First People's Hospital of Kashgar Erea
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This multicenter prospective randomized controlled trial aims to address the clinical gap of accurate, easy-to-use tools to guide peripheral venous access placement for contrast-enhanced CT and MR imaging. At present, venous puncture site selection mainly relies on nurses' personal experience, which may lead to variable cannulation success rates, prolonged operation time and avoidable procedure-related complications.
The study team will build a multi-modal database integrating patients' BMI, physiological parameters, multi-view visible light and near-infrared arm images. Leveraging deep learning techniques including Neural Radiance Field and Swin-Transformer, an AI model will be developed to reconstruct 3D vascular anatomy and recommend optimal puncture sites. The AI tool serves only as a decision-support aid; final puncture decisions remain with nurses under a standardized human-machine coordination framework, where clinicians may accept, modify or reject AI recommendations.
Three participating hospitals will recruit eligible patients and randomly assign them to either the AI-assisted intervention group or routine nursing control group. Standardized image acquisition, venous assessment checklist documentation and post-procedure safety monitoring will be performed uniformly across both groups to ensure data consistency. The trial will also collect process metrics to characterize real-world human-machine interaction, including AI recommendation acceptance rates and handling strategies when AI suggestions conflict with clinical judgment.
Findings from this trial will validate the clinical value and generalizability of the human-machine coordinated puncture workflow, support future clinical translation of the AI venous localization system, and provide evidence to improve the quality and safety of peripheral venous access for contrast-enhanced imaging examinations.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| AI-assisted Human-machine Coordinated Venipuncture | Experimental | Procedure: AI-assisted human-machine coordinated peripheral venipunctureNurses 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. |
| Routine Venipuncture | Active comparator | Procedure: Conventional routine peripheral venipunctureNurses 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-assisted human-machine coordinated peripheral venipuncturePeripheral 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. | Procedure or surgery | AI-assisted Human-machine Coordinated Venipuncture |
| Conventional routine peripheral venipunctureStandard peripheral venous cannulation for contrast-enhanced CT/MRI without AI assistance. Nurses select puncture sites by visual assessment and clinical experience. | Procedure or surgery | Routine Venipuncture |
Primary outcome
First-attempt success rate of peripheral venous cannulation
Time frame: At the time of venous cannulation (intra-procedure)
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.
4 secondary outcomes
Time consumed for peripheral venous cannulation
Time frame: At the time of venous cannulation (intra-procedure)
Patient-reported puncture pain score
Time frame: Immediately after venous cannulation
Overall peripheral venous cannulation success rate
Time frame: At the time of venous cannulation (intra-procedure)
Incidence of contrast extravasation and local vascular injury
Time frame: From cannulation to 24 hours after contrast injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-assisted human-machine coordinated peripheral venipuncture and Conventional routine peripheral venipuncture in people with Peripheral Venous Cannulation for Contrast-enhanced CT/MRI Examination and Peripheral Venous Access Establishment, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hong Deng, Master of Nursing (+86-13580559211, dengh53@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First-attempt success rate of peripheral venous cannulation (time frame: At the time of venous cannulation (intra-procedure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.