[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658606":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":36,"studyPopulation":28,"armGroups":37,"interventions":50,"overallOfficials":28,"centralContacts":60,"locations":66,"responsibleParty":82,"collaborators":84,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":28,"eligibilityCriteria":96,"healthyVolunteers":92,"sex":97,"minAge":28,"maxAge":28,"enrollmentInfo":98,"targetDuration":28,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":108,"overallStatus":114,"whyStopped":28,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":28},[9],{"measure":10,"description":11,"timeFrame":12},"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\u002FMRI. Success is defined as blood return in the catheter and unobstructed contrast medium injection.","At the time of venous cannulation (intra-procedure)",[14,17,21,24],{"measure":15,"description":16,"timeFrame":12},"Time consumed for peripheral venous cannulation","Time duration from touching the skin for puncture preparation to successful venous catheter placement, recorded in seconds.",{"measure":18,"description":19,"timeFrame":20},"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.","Immediately after venous cannulation",{"measure":22,"description":23,"timeFrame":12},"Overall peripheral venous cannulation success rate","Proportion of participants with successful venous access within maximum allowed puncture attempts.",{"measure":25,"description":26,"timeFrame":27},"Incidence of contrast extravasation and local vascular injury","Rate of adverse events including contrast medium extravasation, local hematoma and phlebitis related to venous puncture.","From cannulation to 24 hours after contrast injection",null,{"allocation":30,"interventionModel":31,"interventionModelDescription":32,"primaryPurpose":33,"observationalModel":28,"timePerspective":28,"maskingInfo":34},"RANDOMIZED","PARALLEL","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.","HEALTH_SERVICES_RESEARCH",{"masking":35,"maskingDescription":28,"whoMasked":28},"NONE","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.\n\nThe 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.\n\nThree 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.\n\nFindings 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.",[38,44],{"label":39,"type":40,"description":41,"interventionNames":42},"AI-assisted Human-machine Coordinated Venipuncture","EXPERIMENTAL","Nurses perform peripheral venous cannulation for contrast-enhanced CT\u002FMRI guided by an AI puncture site recommendation system. Nurses may accept, modify or reject AI suggestions under standardized human-machine coordination rules.",[43],"Procedure: AI-assisted human-machine coordinated peripheral venipuncture",{"label":45,"type":46,"description":47,"interventionNames":48},"Routine Venipuncture","ACTIVE_COMPARATOR","Nurses perform peripheral venous cannulation for contrast-enhanced CT\u002FMRI using conventional clinical practice, with puncture site selection based only on clinical experience and visual inspection.",[49],"Procedure: Conventional routine peripheral venipuncture",[51,56],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":28},"PROCEDURE","AI-assisted human-machine coordinated peripheral venipuncture","Peripheral venous cannulation for contrast-enhanced CT\u002FMRI with AI-guided puncture site recommendation. Nurses operate under standardized human-machine coordination rules and may accept, modify or reject AI site suggestions.",[39],{"type":52,"name":57,"description":58,"armGroupLabels":59,"otherNames":28},"Conventional routine peripheral venipuncture","Standard peripheral venous cannulation for contrast-enhanced CT\u002FMRI without AI assistance. Nurses select puncture sites by visual assessment and clinical experience.",[45],[61],{"name":62,"role":63,"phone":64,"phoneExt":28,"email":65},"Hong Deng, Master of Nursing","CONTACT","+86-13580559211","dengh53@mail.sysu.edu.cn",[67],{"facility":68,"status":28,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University","Guangzhou","Guangdong","510120","China","CN",{"type":75,"coordinates":76},"Point",[77,78],113.25,23.11667,{"lat":78,"lon":77},[81],{"name":62,"role":63,"phone":64,"phoneExt":28,"email":65},{"type":83,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[85,87],{"name":86,"class":6},"Eighth Affiliated Hospital, Sun Yat-sen University",{"name":88,"class":89},"The First People's Hospital of Kashgar Erea","UNKNOWN","100658606","venipuncture-via-nurse-ai-collaboration-100658606",false,"NCT07854626","Venipuncture Via Nurse-AI Collaboration","Venipuncture Via Nurse-AI Collaboration: A Multi-Center Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients of all ages scheduled for contrast-enhanced CT\u002FMR examination at three participating centers, who require peripheral venous access.\n* Recent renal function test showing estimated glomerular filtration rate (eGFR) \\> 30 ml\u002Fmin\u002F1.73 m².\n* Written informed consent obtained from the patient or legal representative, agreeing to radiology specialized nursing service.\n\nExclusion Criteria:\n\n* Patients with irreversible brain injury or brain death.\n* Contraindications to peripheral venipuncture, including history of bilateral mastectomy, extremity venous thrombosis, etc.\n* eGFR ≤ 30 ml\u002Fmin\u002F1.73 m².\n* Uncontrolled hyperthyroidism.\n* Patients planned for Iodine-131 therapy within the next two weeks.\n* Extremely poor vascular conditions that make indwelling needle cannulation impossible.\n* Patients receiving contrast-enhanced imaging of both upper limbs.\n* Known contraindications to contrast media.","ALL",{"count":99,"type":100},3500,"ESTIMATED","INTERVENTIONAL",[103],"NA","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\u002FMR contrast scans across three hospitals. The main questions it aims to answer are:\n\nDoes 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.\n\nParticipants will:\n\n* Receive peripheral venous cannulation for contrast-enhanced imaging.\n* Have arm images and clinical data collected before and after puncture.\n* Complete standardized venous access assessment and 24-hour post-procedure safety observation.",[106,107],"Peripheral Venous Cannulation for Contrast-enhanced CT\u002FMRI Examination","Peripheral Venous Access Establishment",[109,110,111,112,113],"Peripheral venous cannulation","Artificial intelligence","Contrast-enhanced CT","Contrast-enhanced MRI","Venipuncture","NOT_YET_RECRUITING","2026-09-28",{"date":117,"type":118},"2026-10-02","ACTUAL",{"date":120,"type":100},"2026-10-15",{"date":122,"type":100},"2027-01-15",{"name":5,"class":6},1]