TruVascular Access - Ultrasound-Guided Vascular Access Study

NCT07798427 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: TWH-TVA-2026-001
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Difficult Intravenous Access; Catheterization, Peripheral; Peripheral Venous Catheterization

Keywords

Ultrasound-Guided Vascular Access; Peripheral Intravenous Catheter; Peripheral IV; PIVC; Vascular Cannulation; First-Attempt Cannulation Success; Difficult Intravenous Access; DIVA; Ultrasound Guidance; Point-of-Care Ultrasound; POCUS; Venipuncture; Vascular Access Device; Catheter Placement; Cannulation Attempts; Peripheral Vein; Real-Time Ultrasound; Procedural Ultrasound; Vascular Access Workflow; TruVascular Access; TVA-2026

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Successful Vascular Access Within Two Cannulation Attempts

  During the initial vascular-access procedure, approximately 30 minutes or less.

• Total Number of Cannulation Attempts

  During the initial vascular-access procedure, approximately 30 minutes or less.

• Time to Successful Peripheral Vascular Access

  During the initial vascular-access procedure, approximately 30 minutes or less.

• Requirement for Rescue or Escalation of Vascular Access

  From initiation of vascular access through completion of the initial access episode, approximately 60 minutes.

• Patient-Reported Procedural Pain

  Immediately following completion of the vascular-access procedure, approximately within 15 minutes.

Other Outcomes (3)

• Point-Biserial Correlation Between Vessel Depth and First-Attempt Cannulation Success

  During the initial vascular-access procedure

• Point-Biserial Correlation Between Vessel Diameter and First-Attempt Cannulation Success

  During the initial vascular-access procedure

• First-Attempt Success Among Participants With Difficult Intravenous Access

  During the initial vascular-access procedure, approximately 30 minutes or less.

Study Arms (2)

Ultrasound-Guided Peripheral Vascular Access

EXPERIMENTAL

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; Device: Point-of-Care Ultrasound System for Vascular Access Guidance

Standard Peripheral Vascular Access

ACTIVE COMPARATOR

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

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.

Ultrasound-Guided Peripheral Vascular Access

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.

Standard Peripheral Vascular Access

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.

Ultrasound-Guided Peripheral Vascular Access

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Truway Health, Inc.: lead

Study Sites (1)

Truway Health, Inc.

New York, New York, 10016, United States

Location

Related Publications (6)

• 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.

  PMID: 33794708 BACKGROUND

• 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.

  PMID: 39837065 BACKGROUND

• 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.

  PMID: 18824276 BACKGROUND

• 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.

  PMID: 26475248 BACKGROUND

• 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.

  PMID: 36727865 BACKGROUND

• 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.

  PMID: 40574336 BACKGROUND

Study Officials

• Gavin C Solomon, M.D.

  Truway Health, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The clinician performing vascular access and the participant cannot practically be blinded to the assigned technique. Where feasible, personnel responsible for adjudicating the primary and selected secondary outcomes will be blinded to treatment assignment using coded procedural records. Statistical analyses may also be conducted using coded study groups prior to final database unblinding.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 1:1 ratio to either an ultrasound-guided peripheral vascular-access group or a standard landmark/visualization/palpation-guided vascular-access group. Both groups will proceed in parallel. The primary comparison will evaluate first-attempt successful peripheral vascular cannulation. Rescue vascular-access procedures are permitted according to protocol-defined safety criteria and clinical necessity.

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: September 1, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): March 31, 2030
• Last Updated: September 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning approximately 12 months after publication of the primary study results and remaining available for 5 years.
• 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.

Locations

US (1)