TruVascular Access - Ultrasound-Guided Vascular Access Study (TVA-2026)

A Prospective Randomized Controlled Study Comparing Ultrasound-Guided Peripheral Vascular Access With Standard Landmark/Palpation-Guided Access for Improving First-Attempt Cannulation Success

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Catheterization, Peripheral; Difficult Intravenous Access; Peripheral Venous Catheterization
• Intervention / Treatment: Procedure: Ultrasound-Guided Peripheral Vascular Access; Device: Point-of-Care Ultrasound System for Vascular Access Guidance; Procedure: Standard Peripheral Vascular Access

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Truway Health, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: Ultrasound-Guided Peripheral Vascular Access; 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.; Device: Point-of-Care Ultrasound System for Vascular Access Guidance; 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.
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.	Procedure: Standard Peripheral Vascular Access; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First-Attempt Peripheral Vascular Cannulation Success	Percentage of participants who achieve successful placement of a functional peripheral vascular catheter on the first cannulation attempt. First-attempt success is defined as successful catheter placement following the first skin puncture/needle insertion associated with the assigned vascular-access procedure, with confirmation of functional vascular access by blood return and/or successful saline flush without immediate evidence of infiltration or extravasation.	During the initial vascular-access procedure, approximately 30 minutes or less.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful Vascular Access Within Two Cannulation Attempts	Percentage of participants who achieve successful placement of a functional peripheral vascular catheter within two cannulation attempts using the initially assigned vascular-access strategy or protocol-defined rescue procedures.	During the initial vascular-access procedure, approximately 30 minutes or less.
Total Number of Cannulation Attempts	Total number of needle insertion attempts required to obtain successful functional peripheral vascular access. Each new skin puncture intended to obtain vascular access will be counted as one attempt.	During the initial vascular-access procedure, approximately 30 minutes or less.
Time to Successful Peripheral Vascular Access	Elapsed time, measured in minutes, from initiation of the assigned vascular-access procedure to confirmation of successful functional peripheral catheter placement.	During the initial vascular-access procedure, approximately 30 minutes or less.
Requirement for Rescue or Escalation of Vascular Access	Percentage of participants requiring a protocol-defined rescue or escalation procedure after unsuccessful or clinically inappropriate continuation of the initially assigned vascular-access strategy. Rescue may include ultrasound guidance, assistance from another clinician, alternative anatomical access, midline placement, peripherally inserted central catheter placement, central venous access, or another clinically appropriate method.	From initiation of vascular access through completion of the initial access episode, approximately 60 minutes.
Patient-Reported Procedural Pain	Participant-reported pain associated with the vascular-access procedure measured using an 11-point Numeric Rating Scale ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain.	Immediately following completion of the vascular-access procedure, approximately within 15 minutes.
Incidence of Vascular Access-Related Complications	Percentage of participants experiencing one or more vascular-access-related complications, including hematoma, bleeding, infiltration, extravasation, accidental arterial puncture, phlebitis, local infection, catheter dislodgement, thrombosis, premature catheter failure, or another clinically significant access-related adverse event.	From vascular-access placement through 72 hours after placement or catheter removal, whichever occurs first.
Functional Catheter Survival	Duration of time that the initially successfully placed peripheral vascular catheter remains functional without unplanned removal, infiltration, occlusion, dislodgement, or other failure requiring replacement.	From successful catheter placement through 72 hours or catheter removal, whichever occurs first.
Patient Satisfaction With Vascular Access Procedure	Participant-reported satisfaction with the vascular-access experience assessed using a protocol-defined 5-point Likert scale ranging from 1, very dissatisfied, to 5, very satisfied.	Immediately following completion of the vascular-access procedure, approximately within 15 minutes.
Operator-Reported Procedural Difficulty	Clinician-reported difficulty of the vascular-access procedure assessed using a protocol-defined 5-point scale ranging from 1, very easy, to 5, very difficult.	Immediately following completion of the vascular-access procedure, approximately within 15 minutes.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Point-Biserial Correlation Between Vessel Depth and First-Attempt Cannulation Success	Point-biserial correlation coefficient (rpb; unitless; possible range -1 to +1) between: (1) target-vessel depth, measured in millimeters from the skin surface to the anterior vessel wall using electronic calipers on B-mode ultrasound before needle insertion; and (2) first-attempt cannulation success, recorded as yes or no on the standardized case-report form according to the protocol-defined first-attempt success criteria. A higher positive coefficient indicates that greater vessel depth is associated with a higher probability of first-attempt success; a negative coefficient indicates an inverse relationship.	During the initial vascular-access procedure
Point-Biserial Correlation Between Vessel Diameter and First-Attempt Cannulation Success	Point-biserial correlation coefficient (rpb; unitless; possible range -1 to +1) between: (1) target-vessel internal diameter, measured in millimeters using electronic calipers on B-mode ultrasound at the intended cannulation site before needle insertion; and (2) first-attempt cannulation success, recorded as yes or no on the standardized case-report form according to the protocol-defined first-attempt success criteria. A higher positive coefficient indicates that greater vessel diameter is associated with a higher probability of first-attempt success; a negative coefficient indicates an inverse relationship.	During the initial vascular-access procedure
First-Attempt Success Among Participants With Difficult Intravenous Access	Percentage of participants meeting protocol-defined difficult intravenous access criteria who achieve successful peripheral vascular catheter placement on the first cannulation attempt, compared between the ultrasound-guided and standard-access study groups.	During the initial vascular-access procedure, approximately 30 minutes or less.

Collaborators and Investigators

• Sponsor: Truway Health, Inc.
• Investigators: Principal Investigator: Gavin C Solomon, M.D., Truway Health, Inc.

Publications and helpful links

General Publications

• Stein J, George B, River G, Hebig A, McDermott D. Ultrasonographically guided peripheral intravenous cannulation in emergency department patients with difficult intravenous access: a randomized trial. Ann Emerg Med. 2009 Jul;54(1):33-40. doi: 10.1016/j.annemergmed.2008.07.048. Epub 2008 Sep 27.
• McCarthy ML, Shokoohi H, Boniface KS, Eggelton R, Lowey A, Lim K, Shesser R, Li X, Zeger SL. Ultrasonography Versus Landmark for Peripheral Intravenous Cannulation: A Randomized Controlled Trial. Ann Emerg Med. 2016 Jul;68(1):10-8. doi: 10.1016/j.annemergmed.2015.09.009. Epub 2015 Oct 23.
• Privitera D, Mazzone A, Pierotti F, Airoldi C, Galazzi A, Geraneo A, Cozzi M, Mora Garrido R, Vailati P, Scaglioni R, Capsoni N, Ganassin EC, Salinaro G, Scala CGR, Dal Molin A. Ultrasound-guided peripheral intravenous catheters insertion in patient with difficult vascular access: Short axis/out-of-plane versus long axis/in-plane, a randomized controlled trial. J Vasc Access. 2022 Jul;23(4):589-597. doi: 10.1177/11297298211006996. Epub 2021 Apr 2.
• Kuo CC, Lee WJ, Ke YT. Ultrasound-guided peripheral intravenous access in adults: A randomized crossover controlled trial. Int Emerg Nurs. 2025 Mar;79:101571. doi: 10.1016/j.ienj.2025.101571. Epub 2025 Jan 20.
• Poulsen E, Aagaard R, Bisgaard J, Sorensen HT, Juhl-Olsen P. The effects of ultrasound guidance on first-attempt success for difficult peripheral intravenous catheterization: a systematic review and meta-analysis. Eur J Emerg Med. 2023 Apr 1;30(2):70-77. doi: 10.1097/MEJ.0000000000000993. Epub 2023 Jan 20.
• Anderssen LM, Petersen MS, Wang AG, Mohr M, Fjallheim AS. The efficacy of ultrasound-guided peripheral intravenous cannulation versus the landmark technique in emergency department patients with difficult intravenous access: A systematic review and meta-analysis. J Vasc Access. 2026 Mar;27(2):435-443. doi: 10.1177/11297298251347816. Epub 2025 Jun 26.

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): March 31, 2030

Study Registration Dates

• First Submitted: August 24, 2026
• First Submitted That Met QC Criteria: August 27, 2026
• First Posted (Actual): September 1, 2026

Study Record Updates

• Last Update Posted (Actual): September 1, 2026
• Last Update Submitted That Met QC Criteria: August 27, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Venipuncture; Peripheral IV; Point-of-Care Ultrasound; POCUS; Ultrasound Guidance; Catheter Placement; DIVA; Peripheral Intravenous Catheter; PIVC; Vascular Access Device; Difficult Intravenous Access; Ultrasound-Guided Vascular Access; Vascular Cannulation; First-Attempt Cannulation Success; Cannulation Attempts; Peripheral Vein; Real-Time Ultrasound; Procedural Ultrasound; Vascular Access Workflow; TruVascular Access; TVA-2026
• Other Study ID Numbers: TWH-TVA-2026-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data underlying the results reported from TVA-2026 may be shared with qualified researchers following completion of the study and publication of the primary study results. Shared data may include participant characteristics, difficult intravenous access variables, randomized study assignment, procedural characteristics, vascular and ultrasound measurements, cannulation attempts, first-attempt success, procedure duration, rescue or escalation events, patient-reported outcomes, catheter outcomes, and protocol-defined safety data. Direct identifiers and information that could reasonably permit participant re-identification will not be shared. Data sharing will be subject to applicable informed-consent provisions, IRB requirements, privacy laws, data-use restrictions, and sponsor review.
• IPD Sharing Time Frame: Beginning approximately 12 months after publication of the primary study results and remaining available for 5 years.
• IPD Sharing Access Criteria: Qualified researchers affiliated with academic institutions, health care organizations, government agencies, or recognized research organizations may request access to de-identified individual participant data and supporting materials. Requests must include a scientifically sound research proposal, investigator credentials, institutional affiliation, intended analyses, data-security safeguards, and proposed publication or dissemination plans. Truway Health, Inc. will review requests for scientific merit, participant privacy, consent limitations, and regulatory compliance. Approved researchers may receive the de-identified IPD dataset, Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report, and analytic code, as applicable. A data-use agreement may be required. Recipients must not attempt participant re-identification or redistribute the data without authorization.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes