TruVascular Access - Ultrasound-Guided Vascular Access Study

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 increase patient discomfort, procedure duration, clinician workload, use of medical supplies, and the likelihood that the patient will require assistance from another clinician or escalation to a more advanced vascular-access procedure. Real-time ultrasound allows clinicians to visualize peripheral vessels and surrounding anatomy during vascular-access procedures and may therefore improve vessel selection and needle guidance, particularly in patients with difficult intravenous access.

TVA-2026 is designed to prospectively compare an ultrasound-guided peripheral vascular-access workflow with conventional vascular-access techniques based primarily on visualization, palpation, and anatomical landmarks.

Participants who require clinically indicated peripheral vascular access and meet study eligibility requirements will be randomized in a 1:1 ratio to one of two study groups.

Ultrasound-Guided Vascular Access Group

Participants assigned to the ultrasound-guided group will undergo peripheral vascular-access placement using real-time ultrasound visualization. The clinician will identify an appropriate peripheral vessel and perform cannulation using a standardized ultrasound-guided approach consistent with the approved study protocol, institutional practice, 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 catheter characteristics, and procedural approach.

Standard Vascular Access Group

Participants assigned to the standard-access group will initially undergo peripheral vascular-access placement using conventional methods such as visual inspection, palpation, anatomical landmarks, tourniquet-assisted vein identification, and other standard clinical techniques that do not initially require real-time ultrasound guidance.

If standard access is unsuccessful within the protocol-defined number of attempts, the treating clinician may use an appropriate rescue technique. Rescue may include ultrasound guidance, assistance from another clinician, use of an alternative anatomical site, or escalation to another clinically appropriate vascular-access method.

Primary Outcome

The primary outcome is first-attempt cannulation success.

First-attempt success will be defined according to the final protocol as successful placement of a functional peripheral vascular catheter following the first needle insertion attempt associated with the assigned vascular-access procedure.

Functional access may be confirmed using clinically appropriate methods such as blood return, successful saline flush, absence of immediate infiltration, or another protocol-defined confirmation procedure.

Secondary Outcomes

Secondary outcomes may include:

Number of cannulation attempts required for successful vascular access. Successful vascular access within two attempts. Time from initiation of the vascular-access procedure to successful catheter placement.

Need for assistance from another clinician. Need for crossover from the initially assigned access method. Need for ultrasound rescue. Need for midline, peripherally inserted central catheter, central venous catheter, or another alternative form of vascular access.

Patient-reported procedural pain. Patient-reported satisfaction with the vascular-access procedure. 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 failure during follow-up when such follow-up is clinically feasible.

Safety Outcomes

Potential access-related safety events may include:

Hematoma. Bleeding. Infiltration. Extravasation. Accidental arterial puncture. Phlebitis. Local infection. Catheter dislodgement. Premature catheter failure. Thrombosis or other clinically significant vascular complications. Other adverse events judged to be related to the vascular-access procedure or study device.

The occurrence, severity, clinical significance, relatedness, and outcome of applicable adverse events will be documented according to the study safety-monitoring plan.

Difficult Intravenous Access Assessment

TVA-2026 will include characterization of participants with potentially difficult intravenous access. Relevant variables may include:

Previous history of difficult vascular access. Poorly visible peripheral veins. Poorly palpable peripheral veins. Previous multiple-attempt catheter placement. Body mass index. Prior vascular procedures. Chronic illness or treatment associated with reduced peripheral venous accessibility.

Other predefined difficult-access characteristics.

A prespecified subgroup analysis may compare study outcomes between participants classified as having difficult intravenous access and those without such classification.

Procedural and Ultrasound Variables

Where available and appropriate to the final protocol, the study may collect additional variables including:

Vessel diameter. Vessel depth. Anatomical access site. Vessel compressibility. Catheter gauge. Catheter length. Needle approach. Ultrasound imaging orientation. Operator training level. Operator vascular-access experience. Operator ultrasound experience. Number of potential vessels identified. Relationship between catheter characteristics and vascular 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 Access

Participant safety and medically necessary care will take priority over research procedures.

Participation in TVA-2026 will not require clinicians to continue repeated unsuccessful attempts solely to preserve study assignment. The protocol will establish a predefined rescue pathway for unsuccessful vascular access.

If continuation of the assigned technique is considered clinically inappropriate, the treating clinician may discontinue the assigned workflow and perform the vascular-access procedure considered appropriate for the participant's clinical condition.

Crossover, rescue access, protocol deviations, and safety-related overrides will be documented and included in the study analysis where applicable.

Operator Training and Standardization

Clinicians participating in the ultrasound-guided arm will be required to meet protocol-defined training or competency criteria before independently performing study procedures.

Training may address:

Ultrasound system operation. Peripheral vessel identification. Differentiation of veins from arteries. Needle visualization. In-plane or out-of-plane ultrasound techniques. Catheter advancement. Confirmation of catheter placement. Infection-prevention procedures. Documentation requirements. Safety and adverse-event reporting.

Operator experience and training status may be retained as study variables because operator competency may influence procedural outcomes.

Data Collection

Research 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 data management. Direct identifiers will be handled according to the study's human-subject protection, 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 and applicable privacy requirements.

Statistical Objectives

The primary statistical analysis will compare first-attempt cannulation success between the 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. Rescue procedures. Escalation of vascular access. Pain scores. Complications. Catheter survival. Patient satisfaction. Operator-reported outcomes.

Additional multivariable analyses may evaluate whether factors such as difficult-access classification, body mass index, vessel depth, vessel diameter, access site, catheter characteristics, and operator experience are associated with successful first-attempt cannulation.

The study is intended to determine whether a standardized ultrasound-guided vascular-access strategy improves procedural success and to characterize the clinical and anatomical factors that may help identify patients most likely to benefit from ultrasound-guided vascular access.

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 will be obtained when required by the reviewing IRB and applicable regulations.
• Vascular access is expected to be performed at an anatomical site suitable for peripheral venous catheterization.
• Participants with or without difficult intravenous access may be enrolled.
• Willing and able to complete protocol-required procedural assessments and follow-up when applicable.

Exclusion criteria

• Immediate life-threatening or emergency circumstances in which study enrollment, consent, assent, parental permission, or randomization could delay medically necessary treatment.
• Existing functional vascular access that eliminates the clinical need for a new peripheral intravenous catheter.
• Clinical requirement for immediate central venous, intraosseous, midline, PICC, or other non-peripheral vascular access rather than peripheral cannulation.
• Infection, significant burn injury, major trauma, vascular injury, or another condition at the proposed access site that makes peripheral cannulation inappropriate.
• Known vascular abnormality or another clinical condition that, in the judgment of the treating clinician or investigator, makes either randomized vascular-access strategy inappropriate or unsafe.
• Inability to undergo either study-assigned vascular-access approach.
• For participants younger than 18 years, inability to satisfy applicable parental permission and assent requirements unless an IRB-approved exception applies.
• Participation in another interventional study that, in the investigator's judgment, could materially interfere with assessment of vascular-access outcomes.
• Any medical, procedural, or logistical circumstance in which participation could interfere with timely delivery of clinically necessary care.