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ENROLLING BY INVITATION

NCT07798427

TruVascular Access - Ultrasound-Guided Vascular Access Study

Sponsor: Truway Health, Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2026-09-15

Completion Date

2030-03-31

Last Updated

2026-09-01

Healthy Volunteers

Conditions

Peripheral Venous Catheterization Difficult Intravenous Access Catheterization, Peripheral

Interventions

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.

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.

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.

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.

Locations (1)

Truway Health, Inc.

New York, New York, United States