A Study to Evaluate SU-VEID™ for Improving Peripheral Venous Access Success in Children

N/ATerminatedNCT05204082

Mayo Clinic169 enrolled

Overview

The purpose of this study is to determine if use of the SU-VEID™ in children facilitates an increase success rate of peripheral intravenous starts, in comparison to the conventional method of vein entry techniques.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

169

Conditions

Intravenous Access

Interventions

Single Use Vein Entry Indicator DeviceDEVICE

Electronic pressure sensing device, integrated to a conventional needle catheter, and which indicates continuously during intravenous cannulation whether the tip of the needle is inside or outside of a vein, to assist a clinician in intravenous cannulation.

Eligibility

Sex: ALLMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patient age \< 18 years old. * Pediatric patients in surgical pre-op (0-18 years old), requiring an I.V. catheter for surgery who are difficult venous access. * Written informed consent/ assent from the patient or legal guardian. Exclusion Criteria: \- Patient age \> 18 years old.

Locations (1)

Mayo Clinic Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Percentage of Participants With IV Access at First Attempt

Percentage of participants to have an IV access within the first attempt when using the SU-VEID Device in comparison to the conventional procedure

Time frame: Baseline

Data from ClinicalTrials.gov

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