Truway Health, Inc.
TruVascular Access - TVA-2026 is a prospective, randomized clinical study evaluating whether ultrasound-guided peripheral vascular access improves first-attempt cannulation success compared with conventional landmark, visualization, and palpation-guided techniques in adults who require clinically indicated peripheral venous access. Participants will be assigned to either an ultrasound-guided vascular-access workflow or a standard vascular-access workflow. The primary outcome is successful placement of a functional peripheral vascular catheter on the first cannulation attempt. Secondary outcomes include the total number of cannulation attempts, time to successful vascular access, successful access within two attempts, need for rescue or escalation to another vascular-access method, patient-reported procedural pain, access-related complications, catheter function, and operator-reported procedural difficulty. The study will also collect information about participant characteristics, difficult intravenous access features, vascular anatomy, catheter characteristics, operator experience, and other procedural factors that may influence successful vascular access. These data may be used to identify patient and procedural characteristics associated with first-attempt success and to improve future vascular-access workflows. Participant safety will take priority over study assignment. If the assigned technique is unsuccessful or clinically inappropriate, the treating clinician may use an alternative or rescue vascular-access method according to applicable clinical practice and study procedures.
Peripheral vascular access is routinely required for the administration of intravenous medications, fluids, diagnostic contrast, blood products, infusion therapies, blood sampling, perioperative care, and other clinical procedures. Although peripheral intravenous catheter placement is common, successful cannulation may be difficult in some patients because of vessel depth, small vessel diameter, limited vein visibility or palpability, body habitus, prior vascular-access procedures, chronic illness, or other anatomical and clinical factors. Repeated unsuccessful cannulation attempts may increa…
Inclusion Criteria: * Age 12 years or older. * Requires peripheral venous vascular access as part of clinically indicated care. * Considered medically appropriate for peripheral intravenous catheter placement. * Able to undergo either ultrasound-guided or standard peripheral vascular-access procedures according to the study protocol. * For participants age 18 years or older, able to provide informed consent or participate under another IRB-approved consent process. * For participants younger than 18 years, permission from a parent or legally authorized representative and participant assent wi…
Peripheral venous catheterization performed with real-time ultrasound guidance. The operator uses ultrasound imaging to identify and assess an appropriate peripheral vessel and to guide needle and catheter placement. The procedure will follow standardized study procedures and applicable clinical practice. Ultrasound findings and procedural variables may include vessel depth, vessel diameter, anatomical location, catheter characteristics, operator experience, number of attempts, procedure duration, and successful catheter placement.
Peripheral venous catheterization performed using conventional vascular-access techniques without initial real-time ultrasound guidance. Vessel selection may be based on visualization, palpation, anatomical landmarks, tourniquet-assisted assessment, and standard clinical judgment. Rescue ultrasound or another clinically appropriate vascular-access method may be used after protocol-defined unsuccessful attempts or whenever clinically necessary.
An FDA-cleared point-of-care B-mode ultrasound imaging system will be used in accordance with its cleared labeling to identify an appropriate peripheral vein, assess vessel depth and diameter, and provide real-time visualization during needle and peripheral intravenous catheter placement. The study evaluates ultrasound-guided vascular-access performance; no investigational modification of the ultrasound system is planned.