TruVascular Access - Ultrasound-Guided Vascular Access Study

Peripheral vascular access is routinely required for the administration of intravenousmedications, fluids, diagnostic contrast, blood products, infusion therapies, bloodsampling, perioperative care, and other clinical procedures. Although peripheralintravenous catheter placement is common, successful cannulation may be difficult in somepatients because of vessel depth, small vessel diameter, limited vein visibility orpalpability, body habitus, prior vascular‐access procedures, chronic illness, or otheranatomical and clinical factors.Repeated unsuccessful cannulation attempts may increase patient discomfort, procedureduration, clinician workload, use of medical supplies, and the likelihood that thepatient will require assistance from another clinician or escalation to a more advancedvascular‐access procedure. Real‐time ultrasound allows clinicians to visualize peripheralvessels and surrounding anatomy during vascular‐access procedures and may thereforeimprove vessel selection and needle guidance, particularly in patients with difficultintravenous access.TVA‐2026 is designed to prospectively compare an ultrasound‐guided peripheralvascular‐access workflow with conventional vascular‐access techniques based primarily onvisualization, palpation, and anatomical landmarks.Participants who require clinically indicated peripheral vascular access and meet studyeligibility requirements will be randomized in a 1:1 ratio to one of two study groups.Ultrasound‐Guided Vascular Access GroupParticipants assigned to the ultrasound‐guided group will undergo peripheralvascular‐access placement using real‐time ultrasound visualization. The clinician willidentify an appropriate peripheral vessel and perform cannulation using a standardizedultrasound‐guided approach consistent with the approved study protocol, institutionalpractice, device instructions for use, and operator training requirements.Where applicable, the study may document vessel characteristics including vessel depth,estimated vessel diameter, anatomical location, compressibility, selected cathetercharacteristics, and procedural approach.Standard Vascular Access GroupParticipants assigned to the standard‐access group will initially undergo peripheralvascular‐access placement using conventional methods such as visual inspection,palpation, anatomical landmarks, tourniquet‐assisted vein identification, and otherstandard clinical techniques that do not initially require real‐time ultrasound guidance.If standard access is unsuccessful within the protocol‐defined number of attempts, thetreating clinician may use an appropriate rescue technique. Rescue may include ultrasoundguidance, assistance from another clinician, use of an alternative anatomical site, orescalation to another clinically appropriate vascular‐access method.Primary OutcomeThe primary outcome is first‐attempt cannulation success.First‐attempt success will be defined according to the final protocol as successfulplacement of a functional peripheral vascular catheter following the first needleinsertion attempt associated with the assigned vascular‐access procedure.Functional access may be confirmed using clinically appropriate methods such as bloodreturn, successful saline flush, absence of immediate infiltration, or anotherprotocol‐defined confirmation procedure.Secondary OutcomesSecondary outcomes may include:Number of cannulation attempts required for successful vascular access. Successfulvascular access within two attempts. Time from initiation of the vascular‐accessprocedure to successful catheter placement.Need for assistance from another clinician. Need for crossover from the initiallyassigned access method. Need for ultrasound rescue. Need for midline, peripherallyinserted central catheter, central venous catheter, or another alternative form ofvascular access.Patient‐reported procedural pain. Patient‐reported satisfaction with the vascular‐accessprocedure. Operator‐reported procedural difficulty. Operator confidence and satisfaction.Number of catheters or related procedural supplies used before successful access.Immediate vascular‐access complications. Catheter function and premature catheter failureduring follow‐up when such follow‐up is clinically feasible.Safety OutcomesPotential access‐related safety events may include:Hematoma. Bleeding. Infiltration. Extravasation. Accidental arterial puncture. Phlebitis.Local infection. Catheter dislodgement. Premature catheter failure. Thrombosis or otherclinically significant vascular complications. Other adverse events judged to be relatedto the vascular‐access procedure or study device.The occurrence, severity, clinical significance, relatedness, and outcome of applicableadverse events will be documented according to the study safety‐monitoring plan.Difficult Intravenous Access AssessmentTVA‐2026 will include characterization of participants with potentially difficultintravenous access. Relevant variables may include:Previous history of difficult vascular access. Poorly visible peripheral veins. Poorlypalpable peripheral veins. Previous multiple‐attempt catheter placement. Body mass index.Prior vascular procedures. Chronic illness or treatment associated with reducedperipheral venous accessibility.Other predefined difficult‐access characteristics.A prespecified subgroup analysis may compare study outcomes between participantsclassified as having difficult intravenous access and those without such classification.Procedural and Ultrasound VariablesWhere available and appropriate to the final protocol, the study may collect additionalvariables including:Vessel diameter. Vessel depth. Anatomical access site. Vessel compressibility. Cathetergauge. Catheter length. Needle approach. Ultrasound imaging orientation. Operatortraining level. Operator vascular‐access experience. Operator ultrasound experience.Number of potential vessels identified. Relationship between catheter characteristics andvascular anatomy.These variables may be evaluated to determine whether specific patient, anatomical,device, or operator characteristics are associated with successful vascular access.Participant Safety and Rescue AccessParticipant safety and medically necessary care will take priority over researchprocedures.Participation in TVA‐2026 will not require clinicians to continue repeated unsuccessfulattempts solely to preserve study assignment. The protocol will establish a predefinedrescue pathway for unsuccessful vascular access.If continuation of the assigned technique is considered clinically inappropriate, thetreating clinician may discontinue the assigned workflow and perform the vascular‐accessprocedure considered appropriate for the participant's clinical condition.Crossover, rescue access, protocol deviations, and safety‐related overrides will bedocumented and included in the study analysis where applicable.Operator Training and StandardizationClinicians participating in the ultrasound‐guided arm will be required to meetprotocol‐defined training or competency criteria before independently performing studyprocedures.Training may address:Ultrasound system operation. Peripheral vessel identification. Differentiation of veinsfrom arteries. Needle visualization. In‐plane or out‐of‐plane ultrasound techniques.Catheter advancement. Confirmation of catheter placement. Infection‐preventionprocedures. Documentation requirements. Safety and adverse‐event reporting.Operator experience and training status may be retained as study variables becauseoperator competency may influence procedural outcomes.Data CollectionResearch data may include demographic, clinical, procedural, device, ultrasound, outcome,safety, and follow‐up information.Participants will be assigned coded study identifiers to support confidentiality and datamanagement. Direct identifiers will be handled according to the study's human‐subjectprotection, privacy, and data‐security procedures.Where ultrasound images are retained for research purposes, image acquisition, storage,coding, access, and de‐identification will be governed by the approved study protocol andapplicable privacy requirements.Statistical ObjectivesThe primary statistical analysis will compare first‐attempt cannulation success betweenthe ultrasound‐guided and standard‐access groups.Secondary analyses may compare the groups with respect to:Number of attempts. Procedure duration. Successful access within two attempts. Rescueprocedures. Escalation of vascular access. Pain scores. Complications. Catheter survival.Patient satisfaction. Operator‐reported outcomes.Additional multivariable analyses may evaluate whether factors such as difficult‐accessclassification, body mass index, vessel depth, vessel diameter, access site, cathetercharacteristics, and operator experience are associated with successful first‐attemptcannulation.The study is intended to determine whether a standardized ultrasound‐guidedvascular‐access strategy improves procedural success and to characterize the clinical andanatomical factors that may help identify patients most likely to benefit fromultrasound‐guided vascular access.