TruVascular Access - Ultrasound-Guided Vascular Access Study

Conditions

• Catheterization, Peripheral
• Difficult Intravenous Access
• Peripheral Venous Catheterization

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ultrasound-Guided Peripheral Vascular Access — PROCEDURE
  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.
• Standard Peripheral Vascular Access — PROCEDURE
  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.
• Point-of-Care Ultrasound System for Vascular Access Guidance — DEVICE
  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.

Study Details

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.

Key Dates

First listed

Sep 1, 2026

Start date

Sep 15, 2026

Status verified

Aug 2026

Primary completion

Sep 30, 2029

Completion

Mar 31, 2030

Study Design

Enrollment

250 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• Experimental: Ultrasound-Guided Peripheral Vascular Access
  Participants assigned to this arm will undergo clinically indicated peripheral vascular access using real-time ultrasound guidance. The operator will use ultrasound visualization to identify an appropriate peripheral vessel and guide needle and catheter placement according to the standardized TVA-2026 vascular-access workflow. Procedural characteristics, number of cannulation attempts, time to successful access, first-attempt success, complications, rescue procedures, and other protocol-defined outcomes will be recorded.
• Active Comparator: Standard Peripheral Vascular Access
  Participants assigned to this arm will undergo clinically indicated peripheral vascular access using conventional techniques, including visual inspection, palpation, anatomical landmarks, and standard vein-selection methods without initial real-time ultrasound guidance. If vascular access cannot be successfully obtained within protocol-defined limits, clinically appropriate rescue or escalation procedures may be used and documented.

Primary Outcome Measure

First-Attempt Peripheral Vascular Cannulation Success [ Time Frame: During the initial vascular-access procedure, approximately 30 minutes or less. ]

Locations (1)

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